Zyston Interbody Spacer System
Str Spacer 7H x 20L x 10W Convex PEEK 10 mm Wide
14manufacturers in China registered for this device type
754catalogue numbers in this listing
5recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shandong (2), Shanghai (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Showing 12 of 14. All 14 manufacturers in China registered for Intervertebral Fusion Device With Bone Graft, Lumbar
Record
| Listed by | Highridge Medical, LLC, United States |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-12-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: keep out of sunlight |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-534618 | Device Size Text, specify—STR TRIAL 18HX20LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534454 | Device Size Text, specify—STR TRIAL 14HX30LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534838 | Device Size Text, specify—STR TRIAL 18HX20LX12W LORDOTIC 12MM WIDE – FIXED | In distribution |
| 14-534429 | Device Size Text, specify—STR TRIAL 9HX30LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 137M0009 | Device Size Text, specify—V Tamp | In distribution |
| 14-533113 | In distribution | |
| 14-534075 | In distribution | |
| 14-534593 | Device Size Text, specify—STR TRIAL 13HX25LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 104M3315 | Device Size Text, specify—Curved Titanium Spacer Lordotic 33L x 15H x 11W 10° | In distribution |
| 14-534011 | In distribution | |
| 14-533035 | Device Size Text, specify—CURVE TRIAL 15HX32L 0 DEG 20 DEG ANGLE | In distribution |
| 14-534010 | In distribution | |
| 14-533027 | Device Size Text, specify—CURVE TRIAL 7HX32L 0 DEG 20 DEG ANGLE | In distribution |
| 136M2808 | Device Size Text, specify—Curved Trial 28L x 08H x 10W mm Parallel | In distribution |
| 14-534678 | Device Size Text, specify—STR TRIAL 18HX25LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534110 | In distribution | |
| 14-534636 | Device Size Text, specify—STR TRIAL 16HX20LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534716 | Device Size Text, specify—STR TRIAL 16HX25LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 104M2810 | Device Size Text, specify—Curved Titanium Spacer Lordotic 28L x 10H x 10W 10° | In distribution |
| 14-534354 | Device Size Text, specify—STR TRIAL 14HX20LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534396 | Device Size Text, specify—STR TRIAL 16HX25LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 136M2816 | Device Size Text, specify—Curved Trial 28L x 16H x 11W mm Parallel | In distribution |
| 101M2611 | Device Size Text, specify—Straight Titanium Spacer Convex 26L x 11H x 10W 0° | In distribution |
| 14-534653 | Device Size Text, specify—STR TRIAL 13HX20LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534298 | In distribution | |
| 104M2813 | Device Size Text, specify—Curved Titanium Spacer Lordotic 28L x 13H x 11W 10° | In distribution |
| 103M2608 | Device Size Text, specify—Straight Titanium Spacer Lordotic 26L x 08H x 10W 10° | In distribution |
| 14-534890 | Device Size Text, specify—STR TRIAL 10HX25LX12W LORDOTIC 12MM WIDE – FIXED | In distribution |
| 14-534416 | Device Size Text, specify—STR TRIAL 16HX25LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534691 | Device Size Text, specify—STR TRIAL 11HX25LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534491 | Device Size Text, specify—STR TRIAL 11HX20LX10W 8 DEG 10MM WIDE – MODULAR LORDOTIC | In distribution |
| 14-534871 | Device Size Text, specify—STR TRIAL 11HX25LX11W LORDOTIC 11MM WIDE – FIXED | In distribution |
| 14-534869 | Device Size Text, specify—STR TRIAL 9HX25LX11W LORDOTIC 11MM WIDE – FIXED | In distribution |
| 104M3314 | Device Size Text, specify—Curved Titanium Spacer Lordotic 33L x 14H x 11W 10° | In distribution |
| 14-534509 | Device Size Text, specify—STR TRIAL 9HX20LX11W 8 DEG 11MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534528 | Device Size Text, specify—STR TRIAL 8HX20LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534655 | Device Size Text, specify—STR TRIAL 15HX20LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534318 | Device Size Text, specify—STR TRIAL 18HX20LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534036 | In distribution | |
| 14-534647 | Device Size Text, specify—STR TRIAL 7HX20LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-533128 | In distribution | |
| 14-534446 | Device Size Text, specify—STR TRIAL 6HX30LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534587 | Device Size Text, specify—STR TRIAL 7HX25LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534195 | In distribution | |
| 14-534338 | Device Size Text, specify—STR TRIAL 18HX20LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534827 | Device Size Text, specify—STR TRIAL 7HX20LX12W LORDOTIC 12MM WIDE – FIXED | In distribution |
| 101M2607 | Device Size Text, specify—Straight Titanium Spacer Convex 26L x 07H x 10W 0° | In distribution |
| 14-534508 | Device Size Text, specify—STR TRIAL 8HX20LX11W 8 DEG 11MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534892 | Device Size Text, specify—STR TRIAL 12HX25LX12W LORDOTIC 12MM WIDE – FIXED | In distribution |
| 14-533112 | In distribution | |
| 14-534729 | Device Size Text, specify—STR TRIAL 9HX30LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534212 | In distribution | |
| 14-534235 | In distribution | |
| 14-534457 | Device Size Text, specify—STR TRIAL 17HX30LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534333 | Device Size Text, specify—STR TRIAL 13HX20LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534176 | In distribution | |
| 14-534478 | Device Size Text, specify—STR TRIAL 18HX30LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534609 | Device Size Text, specify—STR TRIAL 9HX20LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 139M2612 | Device Size Text, specify—Straight Trial 26L x 12H x 10W mm Convex, with Cross Holes | In distribution |
| 14-534690 | Device Size Text, specify—STR TRIAL 10HX25LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534191 | In distribution | |
| 14-534775 | Device Size Text, specify—STR TRIAL 15HX30LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534591 | Device Size Text, specify—STR TRIAL 11HX25LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534370 | Device Size Text, specify—STR TRIAL 10HX25LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534848 | Device Size Text, specify—STR TRIAL 8HX25LX10W LORDOTIC 10MM WIDE – FIXED | In distribution |
| 14-534615 | Device Size Text, specify—STR TRIAL 15HX20LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534073 | In distribution | |
| 14-534533 | Device Size Text, specify—STR TRIAL 13HX20LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534658 | Device Size Text, specify—STR TRIAL 18HX20LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534033 | In distribution | |
| 14-534190 | In distribution | |
| 14-534112 | In distribution | |
| 14-534867 | Device Size Text, specify—STR TRIAL 7HX25LX11W LORDOTIC 11MM WIDE – FIXED | In distribution |
| 14-534088 | In distribution | |
| 14-534829 | Device Size Text, specify—STR TRIAL 9HX20LX12W LORDOTIC 12MM WIDE – FIXED LORDOTIC | In distribution |
| 14-534389 | Device Size Text, specify—STR TRIAL 9HX25LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534651 | Device Size Text, specify—STR TRIAL 11HX20LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534432 | Device Size Text, specify—STR TRIAL 12HX30LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534056 | In distribution | |
| 14-534798 | Device Size Text, specify—STR TRIAL 18HX20LX10W LORDOTIC 10MM WIDE – FIXED | In distribution |
| 14-534790 | Device Size Text, specify—STR TRIAL 10HX20LX10W LORDOTIC 10MM WIDE – FIXED | In distribution |
| 14-534627 | Device Size Text, specify—STR TRIAL 7HX20LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534470 | Device Size Text, specify—STR TRIAL 10HX30LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534598 | Device Size Text, specify—STR TRIAL 18HX25LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-533170 | In distribution | |
| 14-534511 | Device Size Text, specify—STR TRIAL 11HX20LX11W 8 DEG 11MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534136 | In distribution | |
| 14-534456 | Device Size Text, specify—STR TRIAL 16HX30LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534118 | In distribution | |
| 14-534111 | In distribution | |
| 101M2110 | Device Size Text, specify—Straight Titanium Spacer Convex 21L x 10H x 10W 0° | In distribution |
| 101M2613 | Device Size Text, specify—Straight Titanium Spacer Convex 26L x 13H x 11W 0° | In distribution |
| 14-534435 | Device Size Text, specify—STR TRIAL 15HX30LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534387 | Device Size Text, specify—STR TRIAL 7HX25LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534649 | Device Size Text, specify—STR TRIAL 9HX20LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534094 | In distribution | |
| 14-534569 | Device Size Text, specify—STR TRIAL 9HX25LX11W 8 DEG 11MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534116 | In distribution | |
| 14-533016 | Device Size Text, specify—CURVE TRIAL 16HX27L 0 DEG 20 DEG ANGLE | In distribution |
| 14-533031 | Device Size Text, specify—CURVE TRIAL 11HX32L 0 DEG 20 DEG ANGLE | In distribution |
| 14-534309 | Device Size Text, specify—STR TRIAL 9HX20LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-533133 | In distribution | |
| 14-533138 | In distribution | |
| 14-533153 | In distribution | |
| 14-534689 | Device Size Text, specify—STR TRIAL 9HX25LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534537 | Device Size Text, specify—STR TRIAL 17HX20LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534613 | Device Size Text, specify—STR TRIAL 13HX20LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 103M2108 | Device Size Text, specify—Straight Titanium Spacer Lordotic 21L x 08H x 10W 10° | In distribution |
| 14-534527 | Device Size Text, specify—STR TRIAL 7HX20LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534592 | Device Size Text, specify—STR TRIAL 12HX25LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 136M3310 | Device Size Text, specify—Curved Trial 33L x 10H x 10W mm Parallel | In distribution |
| 14-534115 | In distribution | |
| 104M3313 | Device Size Text, specify—Curved Titanium Spacer Lordotic 33L x 13H x 11W 10° | In distribution |
| 14-534594 | Device Size Text, specify—STR TRIAL 14HX25LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534847 | Device Size Text, specify—STR TRIAL 7HX25LX10W LORDOTIC 10MM WIDE – FIXED | In distribution |
| 14-534718 | Device Size Text, specify—STR TRIAL 18HX25LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534590 | Device Size Text, specify—STR TRIAL 10HX25LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534789 | Device Size Text, specify—STR TRIAL 9HX20LX10W LORDOTIC 10MM WIDE – FIXED | In distribution |
| 104M3310 | Device Size Text, specify—Curved Titanium Spacer Lordotic 33L x 10H x 10W 10° | In distribution |
| 14-534272 | In distribution | |
| 14-534668 | Device Size Text, specify—STR TRIAL 8HX25LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534114 | In distribution | |
| 14-534047 | In distribution | |
| 14-534486 | Device Size Text, specify—STR TRIAL 6HX20LX10W 8 DEG 10MM WIDE – MODULAR LORDOTIC | In distribution |
| 14-534556 | Device Size Text, specify—STR TRIAL 16HX25LX10W 8 DEG 10MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534674 | Device Size Text, specify—STR TRIAL 14HX25LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 139M2608 | Device Size Text, specify—Straight Trial 26L x 08H x 10W mm Convex, with Cross Holes | In distribution |
| 14-534133 | In distribution | |
| 139M2611 | Device Size Text, specify—Straight Trial 26L x 11H x 10W mm Convex, with Cross Holes | In distribution |
| 14-533136 | In distribution | |
| 14-534637 | Device Size Text, specify—STR TRIAL 17HX20LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534874 | Device Size Text, specify—STR TRIAL 14HX25LX11W LORDOTIC 11MM WIDE – FIXED | In distribution |
| 14-534886 | Device Size Text, specify—STR TRIAL 6HX25LX12W LORDOTIC 12MM WIDE – FIXED | In distribution |
| 14-534467 | Device Size Text, specify—STR TRIAL 7HX30LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534595 | Device Size Text, specify—STR TRIAL 15HX25LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534049 | In distribution | |
| 14-533167 | In distribution | |
| 14-534495 | Device Size Text, specify—STR TRIAL 15HX20LX10W 8 DEG 10MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534391 | Device Size Text, specify—STR TRIAL 11HX25LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534792 | Device Size Text, specify—STR TRIAL 12HX20LX10W LORDOTIC 10MM WIDE – FIXED | In distribution |
| 14-534791 | Device Size Text, specify—STR TRIAL 11HX20LX10W LORDOTIC 10MM WIDE – FIXED | In distribution |
| 14-534616 | Device Size Text, specify—STR TRIAL 16HX20LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-533107 | In distribution | |
| 14-534277 | In distribution | |
| 14-534574 | Device Size Text, specify—STR TRIAL 14HX25LX11W 8 DEG 11MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534708 | Device Size Text, specify—STR TRIAL 8HX25LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-533150 | In distribution | |
| 14-534050 | In distribution | |
| 103M2110 | Device Size Text, specify—Straight Titanium Spacer Lordotic 21L x 10H x 10W 10° | In distribution |
| 14-534626 | Device Size Text, specify—STR TRIAL 6HX20LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534710 | Device Size Text, specify—STR TRIAL 10HX25LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534553 | Device Size Text, specify—STR TRIAL 13HX25LX10W 8 DEG 10MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534806 | Device Size Text, specify—STR TRIAL 6HX20LX11W LORDOTIC 11MM WIDE – FIXED | In distribution |
| 14-534451 | Device Size Text, specify—STR TRIAL 11HX30LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534767 | Device Size Text, specify—STR TRIAL 7HX30LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534712 | Device Size Text, specify—STR TRIAL 12HX25LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-533134 | In distribution | |
| 101M3114 | Device Size Text, specify—Straight Titanium Spacer Convex 31L x 14H x 11W 0° | In distribution |
| 14-533118 | In distribution | |
| 14-534068 | In distribution | |
| 14-534589 | Device Size Text, specify—STR TRIAL 9HX25LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534696 | Device Size Text, specify—STR TRIAL 16HX25LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-533011 | Device Size Text, specify—CURVE TRIAL 11HX27L 0 DEG 20 DEG ANGLE | In distribution |
| 14-534290 | In distribution | |
| 14-534055 | In distribution | |
| 14-534271 | In distribution | |
| 139M2613 | Device Size Text, specify—Straight Trial 26L x 13H x 11W mm Convex, with Cross Holes | In distribution |
| 14-534128 | In distribution | |
| 14-534394 | Device Size Text, specify—STR TRIAL 14HX25LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 101M2108 | Device Size Text, specify—Straight Titanium Spacer Convex 21L x 08H x 10W 0° | In distribution |
| 14-533017 | Device Size Text, specify—CURVE TRIAL 17HX27L 0 DEG 20 DEG ANGLE | In distribution |
| 14-534733 | Device Size Text, specify—STR TRIAL 13HX30LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534350 | Device Size Text, specify—STR TRIAL 10HX20LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534292 | In distribution | |
| 2343-2210 | In distribution | |
| 104M2815 | Device Size Text, specify—Curved Titanium Spacer Lordotic 28L x 15H x 11W 10° | In distribution |
| 14-534366 | Device Size Text, specify—STR TRIAL 6HX25LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534529 | Device Size Text, specify—STR TRIAL 9HX20LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534468 | Device Size Text, specify—STR TRIAL 8HX30LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534749 | Device Size Text, specify—STR TRIAL 9HX30LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 101M2107 | Device Size Text, specify—Straight Titanium Spacer Convex 21L x 07H x 10W 0° | In distribution |
| 14-534048 | In distribution | |
| 14-534751 | Device Size Text, specify—STR TRIAL 11HX30LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534811 | Device Size Text, specify—STR TRIAL 11HX20LX11W LORDOTIC 11MM WIDE – FIXED | In distribution |
| 14-533156 | In distribution | |
| 14-533034 | Device Size Text, specify—CURVE TRIAL 14HX32L 0 DEG 20 DEG ANGLE | In distribution |
| 14-534156 | In distribution | |
| 137M0020 | Device Size Text, specify—Inner Shaft, C-Clamp | In distribution |
| 14-534295 | In distribution | |
| 130M0025 | In distribution | |
| 14-534853 | Device Size Text, specify—STR TRIAL 13HX25LX10W LORDOTIC 10MM WIDE – FIXED | In distribution |
| 14-534657 | Device Size Text, specify—STR TRIAL 17HX20LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534849 | Device Size Text, specify—STR TRIAL 9HX25LX10W LORDOTIC 10MM WIDE – FIXED | In distribution |
| 14-534868 | Device Size Text, specify—STR TRIAL 8HX25LX11W LORDOTIC 11MM WIDE – FIXED | In distribution |
| 14-534535 | Device Size Text, specify—STR TRIAL 15HX20LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534418 | Device Size Text, specify—STR TRIAL 18HX25LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-533152 | In distribution | |
| 14-534373 | Device Size Text, specify—STR TRIAL 13HX25LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534087 | In distribution | |
| 14-534426 | Device Size Text, specify—STR TRIAL 6HX30LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534196 | In distribution | |
| 14-534234 | In distribution | |
| 14-534409 | Device Size Text, specify—STR TRIAL 9HX25LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534275 | In distribution | |
| 14-534372 | Device Size Text, specify—STR TRIAL 12HX25LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534507 | Device Size Text, specify—STR TRIAL 7HX20LX11W 8 DEG 11MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534228 | In distribution | |
| 14-534635 | Device Size Text, specify—STR TRIAL 15HX20LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-533009 | Device Size Text, specify—CURVE TRIAL 9HX27L 0 DEG 20 DEG ANGLE | In distribution |
| 101M3112 | Device Size Text, specify—Straight Titanium Spacer Convex 31L x 12H x 10W 0° | In distribution |
| 14-534369 | Device Size Text, specify—STR TRIAL 9HX25LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534231 | In distribution | |
| 102M2811 | Device Size Text, specify—Curved Titanium Spacer Parallel 28L x 11H x 10W 0° | In distribution |
| 14-534227 | In distribution | |
| 14-534348 | Device Size Text, specify—STR TRIAL 8HX20LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534093 | In distribution | |
| 14-534754 | Device Size Text, specify—STR TRIAL 14HX30LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-533036 | Device Size Text, specify—CURVE TRIAL 16HX32L 0 DEG 20 DEG ANGLE | In distribution |
| 14-534578 | Device Size Text, specify—STR TRIAL 18HX25LX11W 8 DEG 11MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534170 | In distribution | |
| 14-534586 | Device Size Text, specify—STR TRIAL 6HX25LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534150 | In distribution | |
| 104M3311 | Device Size Text, specify—Curved Titanium Spacer Lordotic 33L x 11H x 10W 10° | In distribution |
| 14-534267 | In distribution | |
| 14-534817 | Device Size Text, specify—STR TRIAL 17HX20LX11W LORDOTIC 11MM WIDE – FIXED | In distribution |
| 14-533115 | In distribution | |
| 14-534692 | Device Size Text, specify—STR TRIAL 12HX25LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534388 | Device Size Text, specify—STR TRIAL 8HX25LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534488 | Device Size Text, specify—STR TRIAL 8HX20LX10W 8 DEG 10MM WIDE – MODULAR LORDOTIC | In distribution |
| 103M2612 | Device Size Text, specify—Straight Titanium Spacer Lordotic 26L x 12H x 10W 10° | In distribution |
| 14-534747 | Device Size Text, specify—STR TRIAL 7HX30LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534496 | Device Size Text, specify—STR TRIAL 16HX20LX10W 8 DEG 10MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534758 | Device Size Text, specify—STR TRIAL 18HX30LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-533174 | In distribution | |
| 14-534109 | In distribution | |
| 102M3311 | Device Size Text, specify—Curved Titanium Spacer Parallel 33L x 11H x 10W 0° | In distribution |
| 136M2806 | Curved Trial 28L x 06H x 10W mm Parallel | In distribution |
| 139M2606 | Straight Trial 26L x 06H x 10W mm | In distribution |
| 14-533171 | In distribution | |
| 14-533114 | In distribution | |
| 14-534096 | In distribution | |
| 14-534210 | In distribution | |
| 14-534575 | Device Size Text, specify—STR TRIAL 15HX25LX11W 8 DEG 11MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534614 | Device Size Text, specify—STR TRIAL 14HX20LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534217 | In distribution | |
| 14-534837 | Device Size Text, specify—STR TRIAL 17HX20LX12W LORDOTIC 12MM WIDE – FIXED | In distribution |
| 14-534809 | Device Size Text, specify—STR TRIAL 9HX20LX11W LORDOTIC 11MM WIDE – FIXED | In distribution |
| 14-534090 | In distribution | |
| 14-534888 | Device Size Text, specify—STR TRIAL 8HX25LX12W LORDOTIC 12MM WIDE – FIXED | In distribution |
| 14-534237 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Peridot Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 10,850 |
| Yellowstone | Summit Spine | 6,654 |
| CoRoent | Nuvasive, Inc. | 5,690 |
| Zavation | Zavation | 2,554 |
| Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2,533 |
| Talos® IBF | Meditech Spine, LLC | 2,163 |
| Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 1,956 |
| TirboLOX-L Lumbar Ibfd | Captiva Spine, Inc. | 1,926 |
| Endoskeleton® TL | Titan Spine, LLC | 1,896 |
| Evos Lumbar Interbody System | Cutting Edge Spine | 1,871 |
| Epiphany | Pantheon Spinal LLC | 1,507 |
| LnK Lumbar Interbody Fusion Cage System | L&K Biomed Co., Ltd. | 1,506 |
Showing 12 of 1,958. All products under Intervertebral Fusion Device With Bone Graft, Lumbar
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-03-16 | Class II | Device Design | Zimmer Biomet is recalling the Altius M-INI OCT Posterior Spinal Fixation System because the driver is unable to mate with the screw head tulip. | 141 | 2018-07-30 |
| 2016-06-30 | Class II | Under Investigation by firm | Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston Transform Instrument Case and Zyston Transform Implant Kit because the locking mechanism on the implant is not functioning as intended. | 5 | 2017-03-15 |
| 2016-06-30 | Class II | Under Investigation by firm | Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston Transform Instrument Case and Zyston Transform Implant Kit because the locking mechanism on the implant is not functioning as intended. | 5 | 2017-03-15 |
| 2012-02-22 | Class II | Nonconforming Material/Component | Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm due to oversize of the set screw hex feature. | 213 | 2015-03-23 |
| 2011-03-09 | Class II | Device Design | Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly. | 120 | 2015-01-07 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P000028 | 2004-06-18 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. |
| P970015 | 2003-09-10 | LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE | Sofamor Danek |
| P980048 | 2001-04-20 | BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM | Sulzer Spine-Tech |
| P950019 | 1999-03-19 | RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION | Stryker Spine |
| P950002 | 1997-06-30 | BAK INTERBODY FUSION SYSTEM | Zimmer Spine, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.