Zyston® Straight Interbody Fusion System
187 catalogue numbers from 14-534571, 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
187catalogue 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 | 2020-06-25 |
| Record revised | 2025-01-03 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-534571 | STR TRIAL 11HX25LX11W 8 DEG 11MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534652 | STR TRIAL 12HX20LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534635 | STR TRIAL 15HX20LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534691 | STR TRIAL 11HX25LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534698 | STR TRIAL 18HX25LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534578 | STR TRIAL 18HX25LX11W 8 DEG 11MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534532 | STR TRIAL 12HX20LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534377 | STR TRIAL 17HX25LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534573 | STR TRIAL 13HX25LX11W 8 DEG 11MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534466 | STR TRIAL 6HX30LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534735 | STR TRIAL 15HX30LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534654 | STR TRIAL 14HX20LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534548 | STR TRIAL 8HX25LX10W 8 DEG 10MM WIDE – MODULAR LORDOTIC | In distribution |
| 14-534902 | STRAIGHT – OFFSET INSERTER | In distribution |
| 14-534597 | STR TRIAL 17HX25LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534558 | STR TRIAL 18HX25LX10W 8 DEG 10MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534546 | STR TRIAL 6HX25LX10W 8 DEG 10MM WIDE – MODULAR LORDOTIC | In distribution |
| 14-534718 | STR TRIAL 18HX25LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534410 | STR TRIAL 10HX25LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534326 | STR TRIAL 6HX20LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534776 | STR TRIAL 16HX30LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534688 | STR TRIAL 8HX25LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534549 | STR TRIAL 9HX25LX10W 8 DEG 10MM WIDE – MODULAR LORDOTIC | In distribution |
| 14-534736 | STR TRIAL 16HX30LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534310 | STR TRIAL 10HX20LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534407 | STR TRIAL 7HX25LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534592 | STR TRIAL 12HX25LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534374 | STR TRIAL 14HX25LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534777 | STR TRIAL 17HX30LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534397 | STR TRIAL 17HX25LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534734 | STR TRIAL 14HX30LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534378 | STR TRIAL 18HX25LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534848 | STR TRIAL 8HX25LX10W LORDOTIC 10MM WIDE – FIXED | In distribution |
| 14-534587 | STR TRIAL 7HX25LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534477 | STR TRIAL 17HX30LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534534 | STR TRIAL 14HX20LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534614 | STR TRIAL 14HX20LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534715 | STR TRIAL 15HX25LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534577 | STR TRIAL 17HX25LX11W 8 DEG 11MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534495 | STR TRIAL 15HX20LX10W 8 DEG 10MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534651 | STR TRIAL 11HX20LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534833 | STR TRIAL 13HX20LX12W LORDOTIC 12MM WIDE – FIXED | In distribution |
| 14-534414 | STR TRIAL 14HX25LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534708 | STR TRIAL 8HX25LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534637 | STR TRIAL 17HX20LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534710 | STR TRIAL 10HX25LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534317 | STR TRIAL 17HX20LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534494 | STR TRIAL 14HX20LX10W 8 DEG 10MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534857 | STR TRIAL 17HX25LX10W LORDOTIC 10MM WIDE – FIXED | In distribution |
| 14-534337 | STR TRIAL 17HX20LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534595 | STR TRIAL 15HX25LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534530 | STR TRIAL 10HX20LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534388 | STR TRIAL 8HX25LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534347 | STR TRIAL 7HX20LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534653 | STR TRIAL 13HX20LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534306 | STR TRIAL 6HX20LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534456 | STR TRIAL 16HX30LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534368 | STR TRIAL 8HX25LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534511 | STR TRIAL 11HX20LX11W 8 DEG 11MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534386 | STR TRIAL 6HX25LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534591 | STR TRIAL 11HX25LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534836 | STR TRIAL 16HX20LX12W LORDOTIC 12MM WIDE – FIXED LORDOTIC | In distribution |
| 14-534551 | STR TRIAL 11HX25LX10W 8 DEG 10MM WIDE – MODULAR LORDOTIC | In distribution |
| 14-534772 | STR TRIAL 12HX30LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534367 | STR TRIAL 7HX25LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534774 | STR TRIAL 14HX30LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534489 | STR TRIAL 9HX20LX10W 8 DEG 10MM WIDE – MODULAR LORDOTIC | In distribution |
| 14-534349 | STR TRIAL 9HX20LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534692 | STR TRIAL 12HX25LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534318 | STR TRIAL 18HX20LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534448 | STR TRIAL 8HX30LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534729 | STR TRIAL 9HX30LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534838 | STR TRIAL 18HX20LX12W LORDOTIC 12MM WIDE – FIXED | In distribution |
| 14-534900 | STRAIGHT – INLINE INSERTER | In distribution |
| 14-534357 | STR TRIAL 17HX20LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534390 | STR TRIAL 10HX25LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534370 | STR TRIAL 10HX25LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534434 | STR TRIAL 14HX30LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534676 | STR TRIAL 16HX25LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534515 | STR TRIAL 15HX20LX11W 8 DEG 11MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534747 | STR TRIAL 7HX30LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534714 | STR TRIAL 14HX25LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534903 | OFFSET – INSERTER INNER SHAFT | In distribution |
| 14-534352 | STR TRIAL 12HX20LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534375 | STR TRIAL 15HX25LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534333 | STR TRIAL 13HX20LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534455 | STR TRIAL 15HX30LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534451 | STR TRIAL 11HX30LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534431 | STR TRIAL 11HX30LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534311 | STR TRIAL 11HX20LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534487 | STR TRIAL 7HX20LX10W 8 DEG 10MM WIDE – MODULAR LORDOTIC | In distribution |
| 14-534667 | STR TRIAL 7HX25LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534751 | STR TRIAL 11HX30LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534632 | STR TRIAL 12HX20LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534706 | STR TRIAL 6HX25LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534626 | STR TRIAL 6HX20LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534417 | STR TRIAL 17HX25LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534518 | STR TRIAL 18HX20LX11W 8 DEG 11MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534613 | STR TRIAL 13HX20LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534554 | STR TRIAL 14HX25LX10W 8 DEG 10MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534330 | STR TRIAL 10HX20LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534596 | STR TRIAL 16HX25LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534358 | STR TRIAL 18HX20LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534450 | STR TRIAL 10HX30LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534570 | STR TRIAL 10HX25LX11W 8 DEG 11MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534527 | STR TRIAL 7HX20LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534746 | STR TRIAL 6HX30LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534758 | STR TRIAL 18HX30LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534506 | STR TRIAL 6HX20LX11W 8 DEG 11MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534598 | STR TRIAL 18HX25LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534606 | STR TRIAL 6HX20LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534634 | STR TRIAL 14HX20LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534709 | STR TRIAL 9HX25LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534336 | STR TRIAL 16HX20LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534905 | STR – T-HANDLE INNER SHAFT | In distribution |
| 14-534446 | STR TRIAL 6HX30LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534901 | STR – INSERTER INNER SHAFT | In distribution |
| 14-534348 | STR TRIAL 8HX20LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534834 | STR TRIAL 14HX20LX12W LORDOTIC 12MM WIDE – FIXED | In distribution |
| 14-534726 | STR TRIAL 6HX30LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534492 | STR TRIAL 12HX20LX10W 8 DEG 10MM WIDE – MODULAR LORDOTIC | In distribution |
| 14-534438 | STR TRIAL 18HX30LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534914 | MOD STR. OFFSET INSERTER | In distribution |
| 14-534353 | STR TRIAL 13HX20LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534610 | STR TRIAL 10HX20LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534346 | STR TRIAL 6HX20LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534753 | STR TRIAL 13HX30LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534611 | STR TRIAL 11HX20LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534389 | STR TRIAL 9HX25LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534413 | STR TRIAL 13HX25LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534469 | STR TRIAL 9HX30LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534556 | STR TRIAL 16HX25LX10W 8 DEG 10MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534617 | STR TRIAL 17HX20LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534488 | STR TRIAL 8HX20LX10W 8 DEG 10MM WIDE – MODULAR LORDOTIC | In distribution |
| 14-534568 | STR TRIAL 8HX25LX11W 8 DEG 11MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534904 | STR – T-HANDLE INSERTER | In distribution |
| 14-534727 | STR TRIAL 7HX30LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534670 | STR TRIAL 10HX25LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534512 | STR TRIAL 12HX20LX11W 8 DEG 11MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534646 | STR TRIAL 6HX20LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534647 | STR TRIAL 7HX20LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534470 | STR TRIAL 10HX30LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534674 | STR TRIAL 14HX25LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534496 | STR TRIAL 16HX20LX10W 8 DEG 10MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534376 | STR TRIAL 16HX25LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534356 | STR TRIAL 16HX20LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534533 | STR TRIAL 13HX20LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534589 | STR TRIAL 9HX25LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534628 | STR TRIAL 8HX20LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534638 | STR TRIAL 18HX20LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534406 | STR TRIAL 6HX25LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534608 | STR TRIAL 8HX20LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534913 | MOD STR. INLINE INSERTER | In distribution |
| 14-534409 | STR TRIAL 9HX25LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534615 | STR TRIAL 15HX20LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534355 | STR TRIAL 15HX20LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534412 | STR TRIAL 12HX25LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534731 | STR TRIAL 11HX30LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534707 | STR TRIAL 7HX25LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534649 | STR TRIAL 9HX20LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534429 | STR TRIAL 9HX30LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534832 | STR TRIAL 12HX20LX12W LORDOTIC 12MM WIDE – FIXED | In distribution |
| 14-534775 | STR TRIAL 15HX30LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534769 | STR TRIAL 9HX30LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534717 | STR TRIAL 17HX25LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534426 | STR TRIAL 6HX30LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534655 | STR TRIAL 15HX20LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534616 | STR TRIAL 16HX20LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534593 | STR TRIAL 13HX25LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534430 | STR TRIAL 10HX30LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534749 | STR TRIAL 9HX30LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534677 | STR TRIAL 17HX25LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534555 | STR TRIAL 15HX25LX10W 8 DEG 10MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534516 | STR TRIAL 16HX20LX11W 8 DEG 11MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534666 | STR TRIAL 6HX25LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534590 | STR TRIAL 10HX25LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534730 | STR TRIAL 10HX30LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534636 | STR TRIAL 16HX20LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534671 | STR TRIAL 11HX25LX10W CONVEX 10MM WIDE – FIXED | In distribution |
| 14-534396 | STR TRIAL 16HX25LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534693 | STR TRIAL 13HX25LX11W CONVEX 11MM WIDE – FIXED | In distribution |
| 14-534350 | STR TRIAL 10HX20LX12W CONVEX 12MM WIDE – MODULAR | In distribution |
| 14-534588 | STR TRIAL 8HX25LX12W 8 DEG 12MM WIDE – MODULAR LORD0TIC | In distribution |
| 14-534334 | STR TRIAL 14HX20LX11W CONVEX 11MM WIDE – MODULAR | In distribution |
| 14-534314 | STR TRIAL 14HX20LX10W CONVEX 10MM WIDE – MODULAR | In distribution |
| 14-534656 | STR TRIAL 16HX20LX12W CONVEX 12MM WIDE – FIXED | In distribution |
| 14-534332 | STR TRIAL 12HX20LX11W CONVEX 11MM WIDE – MODULAR | 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.