Zyston® Strut
125 catalogue numbers from 101M2610, listed by Biomet Spine, United States, under Intervertebral Fusion Device With Bone Graft, Lumbar. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
125catalogue numbers in this listing
5510(k) clearances naming this product 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 | Biomet Spine, United States |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Record published | 2018-07-13 |
| Record revised | 2025-01-03 (version 9) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 101M2610 | Straight Titanium Spacer Convex 26L x 10H x 10W 0° | In distribution |
| 136M2807 | Curved Trial 28L x 07H x 10W mm Parallel | In distribution |
| 101M3107 | Straight Titanium Spacer Convex 31L x 07H x 10W 0° | In distribution |
| 101M3110 | Straight Titanium Spacer Convex 31L x 10H x 10W 0° | In distribution |
| 100M0410 | 10° Curved Soft Case | In distribution |
| 101M2115 | Straight Titanium Spacer Convex 21L x 15H x 11W 0° | In distribution |
| 103M2113 | Straight Titanium Spacer Lordotic 21L x 13H x 11W 10° | In distribution |
| 103M2608 | Straight Titanium Spacer Lordotic 26L x 08H x 10W 10° | In distribution |
| 102M3313 | Curved Titanium Spacer Parallel 33L x 13H x 11W 0° | In distribution |
| 101M3116 | Straight Titanium Spacer Convex 31L x 16H x 11W 0° | In distribution |
| 104M3314 | Curved Titanium Spacer Lordotic 33L x 14H x 11W 10° | In distribution |
| 101M2112 | Straight Titanium Spacer Convex 21L x 12H x 10W 0° | In distribution |
| 104M2812 | Curved Titanium Spacer Lordotic 28L x 12H x 10W 10° | In distribution |
| 100M0210 | Curved Parallel Soft Case | In distribution |
| 136M2811 | Curved Trial 28L x 11H x 10W mm Parallel | In distribution |
| 103M2109 | Straight Titanium Spacer Lordotic 21L x 09H x 10W 10° | In distribution |
| 103M2611 | Straight Titanium Spacer Lordotic 26L x 11H x 10W 10° | In distribution |
| 101M3113 | Straight Titanium Spacer Convex 31L x 13H x 11W 0° | In distribution |
| 136M2814 | Curved Trial 28L x 14H x 11W mm Parallel | In distribution |
| 139M2608 | Straight Trial 26L x 08H x 10W mm Convex, with Cross Holes | In distribution |
| 102M3308 | Curved Titanium Spacer Parallel 33L x 08H x 10W 0° | In distribution |
| 101M3108 | Straight Titanium Spacer Convex 31L x 08H x 10W 0° | In distribution |
| 137M0015 | 90° Reposition Hook | In distribution |
| 103M2609 | Straight Titanium Spacer Lordotic 26L x 09H x 10W 10° | In distribution |
| 102M2811 | Curved Titanium Spacer Parallel 28L x 11H x 10W 0° | In distribution |
| 139M2607 | Straight Trial 26L x 07H x 10W mm Convex, with Cross Holes | In distribution |
| 101M2612 | Straight Titanium Spacer Convex 26L x 12H x 10W 0° | In distribution |
| 102M3315 | Curved Titanium Spacer Parallel 33L x 15H x 11W 0° | In distribution |
| 100M0110 | Straight Convex Soft Case | In distribution |
| 103M2114 | Straight Titanium Spacer Lordotic 21L x 14H x 11W 10° | In distribution |
| 139M2606 | Straight Trial 26L x 06H x 10W mm Convex, with Cross Holes | In distribution |
| 139M2611 | Straight Trial 26L x 11H x 10W mm Convex, with Cross Holes | In distribution |
| 136M3314 | Curved Trial 33L x 14H x 11W mm Parallel | In distribution |
| 103M2613 | Straight Titanium Spacer Lordotic 26L x 13H x 11W 10° | In distribution |
| 136M2815 | Curved Trial 28L x 15H x 11W mm Parallel | In distribution |
| 101M2114 | Straight Titanium Spacer Convex 21L x 14H x 11W 0° | In distribution |
| 137M0005 | Inner Shaft, MIS Inserter | In distribution |
| 101M3109 | Straight Titanium Spacer Convex 31L x 09H x 10W 0° | In distribution |
| 136M3313 | Curved Trial 33L x 13H x 11W mm Parallel | In distribution |
| 101M2116 | Straight Titanium Spacer Convex 21L x 16H x 11W 0° | In distribution |
| 136M3316 | Curved Trial 33L x 16H x 11W mm Parallel | In distribution |
| 104M3311 | Curved Titanium Spacer Lordotic 33L x 11H x 10W 10° | In distribution |
| 101M2107 | Straight Titanium Spacer Convex 21L x 07H x 10W 0° | In distribution |
| 139M2616 | Straight Trial 26L x 16H x 11W mm Convex, with Cross Holes | In distribution |
| 101M2111 | Straight Titanium Spacer Convex 21L x 11H x 10W 0° | In distribution |
| 136M3307 | Curved Trial 33L x 07H x 10W mm Parallel | In distribution |
| 137M0002 | Outer Shaft, Standard Inserter | In distribution |
| 102M2812 | Curved Titanium Spacer Parallel 28L x 12H x 10W 0° | In distribution |
| 139M2612 | Straight Trial 26L x 12H x 10W mm Convex, with Cross Holes | In distribution |
| 136M2810 | Curved Trial 28L x 10H x 10W mm Parallel | In distribution |
| 137M0020 | Inner Shaft, C-Clamp | In distribution |
| 136M3312 | Curved Trial 33L x 12H x 10W mm Parallel | In distribution |
| 104M3307 | Curved Titanium Spacer Lordotic 33L x 07H x 10W 10° | In distribution |
| 102M3314 | Curved Titanium Spacer Parallel 33L x 14H x 11W 0° | In distribution |
| 104M2814 | Curved Titanium Spacer Lordotic 28L x 14H x 11W 10° | In distribution |
| 101M3115 | Straight Titanium Spacer Convex 31L x 15H x 11W 0° | In distribution |
| 101M3114 | Straight Titanium Spacer Convex 31L x 14H x 11W 0° | In distribution |
| 136M3309 | Curved Trial 33L x 09H x 10W mm Parallel | In distribution |
| 136M2812 | Curved Trial 28L x 12H x 10W mm Parallel | In distribution |
| 101M2608 | Straight Titanium Spacer Convex 26L x 08H x 10W 0° | In distribution |
| 101M2113 | Straight Titanium Spacer Convex 21L x 13H x 11W 0° | In distribution |
| 103M2610 | Straight Titanium Spacer Lordotic 26L x 10H x 10W 10° | In distribution |
| 103M2112 | Straight Titanium Spacer Lordotic 21L x 12H x 10W 10° | In distribution |
| 101M2611 | Straight Titanium Spacer Convex 26L x 11H x 10W 0° | In distribution |
| 104M2815 | Curved Titanium Spacer Lordotic 28L x 15H x 11W 10° | In distribution |
| 136M3311 | Curved Trial 33L x 11H x 10W mm Parallel | In distribution |
| 104M2811 | Curved Titanium Spacer Lordotic 28L x 11H x 10W 10° | In distribution |
| 103M2111 | Straight Titanium Spacer Lordotic 21L x 11H x 10W 10° | In distribution |
| 136M2813 | Curved Trial 28L x 13H x 11W mm Parallel | In distribution |
| 101M2607 | Straight Titanium Spacer Convex 26L x 07H x 10W 0° | In distribution |
| 136M3306 | Curved Trial 33L x 06H x 10W mm Parallel | In distribution |
| 101M3111 | Straight Titanium Spacer Convex 31L x 11H x 10W 0° | In distribution |
| 102M2814 | Curved Titanium Spacer Parallel 28L x 14H x 11W 0° | In distribution |
| 104M3308 | Curved Titanium Spacer Lordotic 33L x 08H x 10W 10° | In distribution |
| 104M3310 | Curved Titanium Spacer Lordotic 33L x 10H x 10W 10° | In distribution |
| 101M3112 | Straight Titanium Spacer Convex 31L x 12H x 10W 0° | In distribution |
| 139M2609 | Straight Trial 26L x 09H x 10W mm Convex, with Cross Holes | In distribution |
| 102M2810 | Curved Titanium Spacer Parallel 28L x 10H x 10W 0° | In distribution |
| 104M2808 | Curved Titanium Spacer Lordotic 28L x 08H x 10W 10° | In distribution |
| 139M2614 | Straight Trial 26L x 14H x 11W mm Convex, with Cross Holes | In distribution |
| 139M2615 | Straight Trial 26L x 15H x 11W mm Convex, with Cross Holes | In distribution |
| 136M3310 | Curved Trial 33L x 10H x 10W mm Parallel | In distribution |
| 139M2610 | Straight Trial 26L x 10H x 10W mm Convex, with Cross Holes | In distribution |
| 104M3315 | Curved Titanium Spacer Lordotic 33L x 15H x 11W 10° | In distribution |
| 136M2809 | Curved Trial 28L x 09H x 10W mm Parallel | In distribution |
| 139M2613 | Straight Trial 26L x 13H x 11W mm Convex, with Cross Holes | In distribution |
| 102M2808 | Curved Titanium Spacer Parallel 28L x 08H x 10W 0° | In distribution |
| 136M3308 | Curved Trial 33L x 08H x 10W mm Parallel | In distribution |
| 104M3312 | Curved Titanium Spacer Lordotic 33L x 12H x 10W 10° | In distribution |
| 102M3307 | Curved Titanium Spacer Parallel 33L x 07H x 10W 0° | In distribution |
| 104M3309 | Curved Titanium Spacer Lordotic 33L x 09H x 10W 10° | In distribution |
| 104M3313 | Curved Titanium Spacer Lordotic 33L x 13H x 11W 10° | In distribution |
| 137M0017 | Med Slap Hammer Adapter Fork | In distribution |
| 103M2107 | Straight Titanium Spacer Lordotic 21L x 07H x 10W 10° | In distribution |
| 101M2613 | Straight Titanium Spacer Convex 26L x 13H x 11W 0° | In distribution |
| 137M0004 | Outer Shaft, MIS Inserter | In distribution |
| 101M2109 | Straight Titanium Spacer Convex 21L x 09H x 10W 0° | In distribution |
| 104M2809 | Curved Titanium Spacer Lordotic 28L x 09H x 10W 10° | In distribution |
| 101M2615 | Straight Titanium Spacer Convex 26L x 15H x 11W 0° | In distribution |
| 102M2807 | Curved Titanium Spacer Parallel 28L x 07H x 10W 0° | In distribution |
| 102M2809 | Curved Titanium Spacer Parallel 28L x 09H x 10W 0° | In distribution |
| 102M3310 | Curved Titanium Spacer Parallel 33L x 10H x 10W 0° | In distribution |
| 102M2815 | Curved Titanium Spacer Parallel 28L x 15H x 11W 0° | In distribution |
| 103M2108 | Straight Titanium Spacer Lordotic 21L x 08H x 10W 10° | In distribution |
| 136M2806 | Curved Trial 28L x 06H x 10W mm Parallel | In distribution |
| 137M0003 | Inner Shaft, Standard Inserter | In distribution |
| 136M2816 | Curved Trial 28L x 16H x 11W mm Parallel | In distribution |
| 102M3312 | Curved Titanium Spacer Parallel 33L x 12H x 10W 0° | In distribution |
| 103M2110 | Straight Titanium Spacer Lordotic 21L x 10H x 10W 10° | In distribution |
| 100M0310 | 10° Straight Soft Case | In distribution |
| 103M2612 | Straight Titanium Spacer Lordotic 26L x 12H x 10W 10° | In distribution |
| 102M3309 | Curved Titanium Spacer Parallel 33L x 09H x 10W 0° | In distribution |
| 101M2614 | Straight Titanium Spacer Convex 26L x 14H x 11W 0° | In distribution |
| 102M2813 | Curved Titanium Spacer Parallel 28L x 13H x 11W 0° | In distribution |
| 101M2108 | Straight Titanium Spacer Convex 21L x 08H x 10W 0° | In distribution |
| 136M3315 | Curved Trial 33L x 15H x 11W mm Parallel | In distribution |
| 104M2813 | Curved Titanium Spacer Lordotic 28L x 13H x 11W 10° | In distribution |
| 137M0019 | Outer Shaft, C-Clamp | In distribution |
| 101M2110 | Straight Titanium Spacer Convex 21L x 10H x 10W 0° | In distribution |
| 101M2616 | Straight Titanium Spacer Convex 26L x 16H x 11W 0° | In distribution |
| 103M2614 | Straight Titanium Spacer Lordotic 26L x 14H x 11W 10° | In distribution |
| 101M2609 | Straight Titanium Spacer Convex 26L x 09H x 10W 0° | In distribution |
| 136M2808 | Curved Trial 28L x 08H x 10W mm Parallel | In distribution |
| 102M3311 | Curved Titanium Spacer Parallel 33L x 11H x 10W 0° | In distribution |
| 104M2810 | Curved Titanium Spacer Lordotic 28L x 10H x 10W 10° | In distribution |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153695 | 2016-01-21 |
| K151483 | 2015-07-31 |
| K142634 | 2015-03-12 |
| K112014 | 2011-10-17 |
| K081636 | 2008-08-07 |
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.