Tyber Medical
PLIF 22mm x 12mm x 9mm x 0 °, TyPEEK, SterilePLIF 22mm x 12mm x 9mm x 0 °, TyPEEK, Sterile
14manufacturers in China registered for this device type
617catalogue numbers in this listing
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 | Tyber Medical, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K130573 |
| Record published | 2018-02-02 |
| Record revised | 2025-08-15 (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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 302-P301728-S | In distribution | |
| 302-P2417412-S | In distribution | |
| 002-T3011002 | In distribution | |
| 302-P249012-S | In distribution | |
| 502-P3017010-S | In distribution | |
| 302-P268410-S | In distribution | |
| 302-P24908-S | In distribution | |
| 502-P241508-S | In distribution | |
| 502-P2817812-S | In distribution | |
| 502-P301108-S | In distribution | |
| 302-P249410-S | In distribution | |
| 502-P261708-S | In distribution | |
| 302-P247812-S | In distribution | |
| 002-P261588 | In distribution | |
| 502-P229410-S | In distribution | |
| 502-P2417812-S | In distribution | |
| 302-P221548-S | In distribution | |
| 502-P2812412-S | In distribution | |
| 302-P2810412-S | In distribution | |
| 502-P2810412-S | In distribution | |
| 502-P2415410-S | In distribution | |
| 502-P268010-S | In distribution | |
| 502-P2411012-S | In distribution | |
| 002-C141252 | In distribution | |
| 302-P321108-S | In distribution | |
| 502-P261488-S | In distribution | |
| 502-P248410-S | In distribution | |
| 302-P2417810-S | In distribution | |
| 302-P2215012-S | In distribution | |
| 302-P289412-S | In distribution | |
| 35-14120509 | In distribution | |
| 502-P2413412-S | In distribution | |
| 502-P30828-S | In distribution | |
| 302-P2413412-S | In distribution | |
| 302-P227010-S | In distribution | |
| 302-P2811812-S | In distribution | |
| 502-P301228-S | In distribution | |
| 302-P2614010-S | In distribution | |
| 35-14120511 | In distribution | |
| 002-C14975 | In distribution | |
| 502-P2213412-S | In distribution | |
| 302-P301308-S | In distribution | |
| 302-P2814812-S | In distribution | |
| SV2710P | In distribution | |
| 002-000009 | In distribution | |
| 502-P2217012-S | In distribution | |
| 502-P227012-S | In distribution | |
| 502-P24708-S | In distribution | |
| 302-P2212010-S | In distribution | |
| 002-C14955 | In distribution | |
| 302-P241088-S | In distribution | |
| 302-P2815412-S | In distribution | |
| 302-P227410-S | In distribution | |
| 502-P2410410-S | In distribution | |
| 502-P301008-S | In distribution | |
| 302-P247410-S | In distribution | |
| PLIF 26mm x 8mm x 13mm x 0 Degree | In distribution | |
| 302-P2817410-S | In distribution | |
| 502-P2417412-S | In distribution | |
| PLIF 26mm x 8mm x 11mm x 0 Degree | In distribution | |
| 002-T2810004 | In distribution | |
| 502-P2815410-S | In distribution | |
| 502-P241288-S | In distribution | |
| 502-P2815812-S | In distribution | |
| 502-P221608-S | In distribution | |
| 502-P2412010-S | In distribution | |
| 302-P2617010-S | In distribution | |
| 502-P2413810-S | In distribution | |
| M2-P288410-S | In distribution | |
| 302-P2413810-S | In distribution | |
| 302-P2411810-S | In distribution | |
| 302-P2212812-S | In distribution | |
| 502-P241488-S | In distribution | |
| 302-P2815812-S | In distribution | |
| 302-P249010-S | In distribution | |
| 35-14120508 | In distribution | |
| 302-P261048-S | In distribution | |
| 302-P221088-S | In distribution | |
| 502-P2216810-S | In distribution | |
| 502-P261088-S | In distribution | |
| 302-P2412012-S | In distribution | |
| 502-P2417810-S | In distribution | |
| 302-P308010-S | In distribution | |
| PLIF 26mm x 12mm x 17mm x 0 degree | In distribution | |
| 502-P248810-S | In distribution | |
| 302-P2812012-S | In distribution | |
| 502-P2816812-S | In distribution | |
| 502-P2814412-S | In distribution | |
| 502-P26908-S | In distribution | |
| 502-P2216812-S | In distribution | |
| 302-P221248-S | In distribution | |
| 502-P261248-S | In distribution | |
| 302-P301508-S | In distribution | |
| 302-P221188-S | In distribution | |
| 502-P261288-S | In distribution | |
| 502-P249010-S | In distribution | |
| 502-P261208-S | In distribution | |
| M2-P2811410-S | In distribution | |
| 502-P2216010-S | In distribution | |
| M2-P2810810-S | In distribution | |
| 502-T2817501-S | In distribution | |
| 302-P2213012-S | In distribution | |
| 502-P3014010-S | In distribution | |
| 502-P261288-S | In distribution | |
| 302-P2813812-S | In distribution | |
| 302-P2813810-S | In distribution | |
| 302-P2417012-S | In distribution | |
| 25-26100708 | In distribution | |
| 502-P2616410-S | In distribution | |
| 502-P2810810-S | In distribution | |
| 302-P3011010-S | In distribution | |
| 302-P221788-S | In distribution | |
| 502-P2415810-S | In distribution | |
| 502-P24788-S | In distribution | |
| 502-P2617410-S | In distribution | |
| 302-P221588-S | In distribution | |
| 302-P248412-S | In distribution | |
| 502-P301408-S | In distribution | |
| 502-P227810-S | In distribution | |
| 502-P247412-S | In distribution | |
| 502-P2814810-S | In distribution | |
| 302-P267410-S | In distribution | |
| 302-P2413012-S | In distribution | |
| 502-P2413410-S | In distribution | |
| 502-P261148-S | In distribution | |
| M2-P2817810-S | In distribution | |
| 502-P2611010-S | In distribution | |
| 502-P2210010-S | In distribution | |
| PLIF 26mm x 8mm x 8mm x 0 Degree | In distribution | |
| 302-P301408-S | In distribution | |
| SV2713P | In distribution | |
| 502-P241788-S | In distribution | |
| 502-P249012-S | In distribution | |
| 002-P261748 | In distribution | |
| 302-P229410-S | In distribution | |
| 25-00000009 | In distribution | |
| 302-P289812-S | In distribution | |
| 502-P2612010-S | In distribution | |
| 302-P2813412-S | In distribution | |
| 302-P3016010-S | In distribution | |
| 302-P2415810-S | In distribution | |
| 302-P261788-S | In distribution | |
| 002-P261348 | In distribution | |
| 002-C14575 | In distribution | |
| 502-P321108-S | In distribution | |
| 502-P307210-S | In distribution | |
| 502-P2612810-S | In distribution | |
| 002-T288004 | In distribution | |
| 302-P248810-S | In distribution | |
| 502-P261548-S | In distribution | |
| 502-P241348-S | In distribution | |
| 502-P2610410-S | In distribution | |
| 302-P2210810-S | In distribution | |
| 002-P261688 | In distribution | |
| 502-P2415412-S | In distribution | |
| 502-P24808-S | In distribution | |
| 302-P2811012-S | In distribution | |
| 502-P2812810-S | In distribution | |
| 502-P2214012-S | In distribution | |
| 502-P2613410-S | In distribution | |
| 502-P248012-S | In distribution | |
| 302-P241508-S | In distribution | |
| 302-P2810810-S | In distribution | |
| 502-P2412012-S | In distribution | |
| 302-P249412-S | In distribution | |
| 302-P261708-S | In distribution | |
| 502-P2810812-S | In distribution | |
| 002-P261608 | In distribution | |
| 502-P221548-S | In distribution | |
| 502-P2410412-S | In distribution | |
| 302-P301528-S | In distribution | |
| 302-P241188-S | In distribution | |
| 502-P24848-S | In distribution | |
| 002-P32908 | In distribution | |
| 302-P2417010-S | In distribution | |
| 502-P24988-S | In distribution | |
| 302-P2815810-S | In distribution | |
| 302-P2217810-S | In distribution | |
| 302-P2610010-S | In distribution | |
| 302-P3017010-S | In distribution | |
| 502-P2412812-S | In distribution | |
| 302-P241588-S | In distribution | |
| 302-P30708-S | In distribution | |
| 302-P2415010-S | In distribution | |
| 302-P2410810-S | In distribution | |
| 302-P2411012-S | In distribution | |
| 502-P2813012-S | In distribution | |
| M2-P2815410-S | In distribution | |
| 502-P2615010-S | In distribution | |
| 502-P2816810-S | In distribution | |
| 502-P2811412-S | In distribution | |
| 502-P241748-S | In distribution | |
| 502-P221248-S | In distribution | |
| 502-P2214812-S | In distribution | |
| PLIF 26mm x 10mm x 16mm x 0 Degree | In distribution | |
| 502-P289812-S | In distribution | |
| 502-P2211012-S | In distribution | |
| PLIF 26mm x 8mm x 15mm x 0 Degree | In distribution | |
| 302-P26948-S | In distribution | |
| 302-P2217010-S | In distribution | |
| 302-P2411812-S | In distribution | |
| 302-P241388-S | In distribution | |
| 502-P2416010-S | In distribution | |
| 502-P287412-S | In distribution | |
| PLIF 26mm x 8mm x 17mm x 0 Degree | In distribution | |
| 302-P2410410-S | In distribution | |
| 502-P241088-S | In distribution | |
| 002-P261308 | In distribution | |
| 302-P288812-S | In distribution | |
| 502-P2817410-S | In distribution | |
| 502-P2213810-S | In distribution | |
| 502-P221788-S | In distribution | |
| 502-P2416412-S | In distribution | |
| 302-P261448-S | In distribution | |
| 002-P321308 | In distribution | |
| PLIF 26mm x 10mm x 12mm x 0 Degree | In distribution | |
| 502-P287012-S | In distribution | |
| 302-P2215412-S | In distribution | |
| 502-P248010-S | In distribution | |
| 502-P261648-S | In distribution | |
| 302-P22908-S | In distribution | |
| PLIF 26mm x 12mm x 13mm x 0 degree | In distribution | |
| 302-P2215010-S | In distribution | |
| 302-P268010-S | In distribution | |
| 502-P229012-S | In distribution | |
| 502-P30808-S | In distribution | |
| 502-P30908-S | In distribution | |
| 502-P228010-S | In distribution | |
| 502-P2212010-S | In distribution | |
| 502-P2414012-S | In distribution | |
| 302-P228812-S | In distribution | |
| 302-P2411412-S | In distribution | |
| 302-P261308-S | In distribution | |
| 502-P2412410-S | In distribution | |
| M2-P2814810-S | In distribution | |
| 302-P288810-S | In distribution | |
| 302-P229010-S | In distribution | |
| SV2715P | In distribution | |
| 502-P221688-S | In distribution | |
| 502-P261108-S | In distribution | |
| 302-P261348-S | In distribution | |
| 302-P221008-S | In distribution | |
| 302-P241348-S | In distribution | |
| 302-P2810012-S | In distribution | |
| 502-P2812012-S | In distribution | |
| 302-P261408-S | In distribution | |
| 302-P2817810-S | In distribution | |
| 502-P2813412-S | In distribution | |
| 502-P2414410-S | In distribution | |
| 502-P2614410-S | 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
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.