Timberline® MPF Lateral Interbody Modular Plate Fixation System
107 catalogue numbers from 8603-6016, 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
107catalogue 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 | 2020-07-13 |
| Record revised | 2025-01-03 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8603-6016 | Spacer MPF PEEK 0° 60L x 22W x 16Hmm | In distribution |
| 8610-5540 | Screw Fixed Bicortical Ti ø5.5x40mm | In distribution |
| 8602-4510 | Spacer MPF PEEK 8° 45L x 18W x 10Hmm | In distribution |
| 8620-5008 | Spacer Lat PEEK Spiked 0° 50L X 22W X 08 | In distribution |
| 8621-5014 | MPF SPACER 18X50X14 14DEG ASSY | In distribution |
| 8620-4008 | Spacer Lat PEEK Spiked 0° 40L X 22W X 08 | In distribution |
| 8605-0214 | Plate 2 Hole Ti 14mm Assy | In distribution |
| 8621-4020 | MPF SPACER 18X40X20 14DEG ASSY | In distribution |
| 8604-5510 | Spacer MPF PEEK 8° 55L x 22W x 10Hmm | In distribution |
| 8601-6008 | Spacer MPF PEEK 0° 60L x 18W x 8Hmm | In distribution |
| 8603-4516 | Spacer MPF PEEK 0° 45L x 22W x 16Hmm | In distribution |
| 8622-5010 | MPF SPACER 22X50X10 14DEG ASSY | In distribution |
| 8605-0016 | Plate Plug Ti 16mm Assy | In distribution |
| 8610-6055 | Screw Fixed Bicortical Ti ø6.0x55mm | In distribution |
| 8605-0406 | Plate 4 Hole Ti 6mm Assy | In distribution |
| 8609-5555 | Screw Bicortical Ti ø5.5x55mm | In distribution |
| 8602-5012 | Spacer MPF PEEK 8° 50L x 18W x 12Hmm | In distribution |
| 8601-5016 | Spacer MPF PEEK 0° 50L x 18W x 16Hmm | In distribution |
| 8621-4516 | MPF SPACER 18X45X16 14DEG ASSY | In distribution |
| 8604-5010 | Spacer MPF PEEK 8° 50L x 22W x 10Hmm | In distribution |
| 8603-5516 | Spacer MPF PEEK 0° 55L x 22W x 16Hmm | In distribution |
| 8620-5014 | Spacer Lat PEEK Spiked 0° 50L X 22W X 14 | In distribution |
| 8607-6030 | Screw Self-Tapping Ti ø6.0x30mm | In distribution |
| 8620-5010 | Spacer Lat PEEK Spiked 0° 50L X 22W X 10 | In distribution |
| 8604-4014 | Spacer MPF PEEK 8° 40L x 22W x 14Hmm | In distribution |
| 8614-5518 | Spacer MPF PEEK 30° 55L x 22W x 18H | In distribution |
| 8601-5510 | Spacer MPF PEEK 0° 55L x 18W x 10Hmm | In distribution |
| 8610-5560 | Screw Fixed Bicortical Ti ø5.5x60mm | In distribution |
| 8609-5055 | Screw Bicortical Ti ø5.0x55mm | In distribution |
| 8602-4012 | Spacer MPF PEEK 8° 40L x 18W x 12Hmm | In distribution |
| 8615-5516 | SPACER MPF PEEK 0DEG 55L X 26W X 16HMM | In distribution |
| 8602-5010 | Spacer MPF PEEK 8° 50L x 18W x 10Hmm | In distribution |
| 8616-5510 | SPACER MPF PEEK 8DEG 55L X 26W X 10HMM | In distribution |
| 8608-6055 | Screw Fixed Self-Tapping Ti ø6.0x55mm | In distribution |
| 8615-5508 | SPACER MPF PEEK 0DEG 55L X 26W X 8HMM | In distribution |
| 8602-5016 | Spacer MPF PEEK 8° 50L x 18W x 16Hmm | In distribution |
| 8604-5014 | Spacer MPF PEEK 8° 50L x 22W x 14Hmm | In distribution |
| 8620-6012 | Spacer Lat PEEK Spiked 0° 60L X 22W X 12 | In distribution |
| 8614-4020 | Spacer MPF PEEK 30° 40L x 22W x 20H | In distribution |
| 8620-5012 | Spacer Lat PEEK Spiked 0° 50L X 22W X 12 | In distribution |
| 8605-0212 | Plate 2 Hole Ti 12mm Assy | In distribution |
| 8618-5018 | Spacer MPF PEEK 25° 50L x 22W x 18H | In distribution |
| 8613-5014 | Spacer MPF PEEK 20° 50L x 22W x 14H | In distribution |
| 8621-6018 | MPF SPACER 18X60X18 14DEG ASSY | In distribution |
| 8601-5512 | Spacer MPF PEEK 0° 55L x 18W x 12Hmm | In distribution |
| 8614-5516 | Spacer MPF PEEK 30° 55L x 22W x 16H | In distribution |
| 8604-4008 | Spacer MPF PEEK 8° 40L x 22W x 8Hmm | In distribution |
| 8609-5060 | Screw Bicortical Ti ø5.0x60mm | In distribution |
| 8602-4514 | Spacer MPF PEEK 8° 45L x 18W x 14Hmm | In distribution |
| 8616-5512 | SPACER MPF PEEK 8DEG 55L X 26W X 12HMM | In distribution |
| 8614-4014 | Spacer MPF PEEK 30° 40L x 22W x 14H | In distribution |
| 8620-5508 | Spacer Lat PEEK Spiked 0° 55L X 22W X 08 | In distribution |
| 8621-5520 | MPF SPACER 18X55X20 14DEG ASSY | In distribution |
| 8620-6010 | Spacer Lat PEEK Spiked 0° 60L X 22W X 10 | In distribution |
| 8622-4518 | MPF SPACER 22X45X18 14DEG ASSY | In distribution |
| 8610-5555 | Screw Fixed Bicortical Ti ø5.5x55mm | In distribution |
| 8613-6016 | Spacer MPF PEEK 20° 60L x 22W x 16H | In distribution |
| 8620-4012 | Spacer Lat PEEK Spiked 0° 40L X 22W X 12 | In distribution |
| 8607-6060 | Screw Self-Tapping Ti ø6.0x60mm | In distribution |
| 8618-5014 | Spacer MPF PEEK 25° 50L x 22W x 14H | In distribution |
| 8601-6010 | Spacer MPF PEEK 0° 60L x 18W x 10Hmm | In distribution |
| 8615-4008 | SPACER MPF PEEK 0DEG 40L X 26W X 8HMM | In distribution |
| 8613-5518 | Spacer MPF PEEK 20° 55L x 22W x 18H | In distribution |
| 8603-5508 | Spacer MPF PEEK 0° 55L x 22W x 8Hmm | In distribution |
| 8610-6040 | Screw Fixed Bicortical Ti ø6.0x40mm | In distribution |
| 8604-5012 | Spacer MPF PEEK 8° 50L x 22W x 12Hmm | In distribution |
| 8615-4014 | SPACER MPF PEEK 0DEG 40L X 26W X 14HMM | In distribution |
| 8601-4516 | Spacer MPF PEEK 0° 45L x 18W x 16Hmm | In distribution |
| 8601-4512 | Spacer MPF PEEK 0° 45L x 18W x 12Hmm | In distribution |
| 8607-5550 | Screw Self-Tapping Ti ø5.5x50mm | In distribution |
| 8605-0316 | Plate 3 Hole Ti 16mm Assy | In distribution |
| 8604-5008 | Spacer MPF PEEK 8° 50L x 22W x 8Hmm | In distribution |
| 8601-4508 | Spacer MPF PEEK 0° 45L x 18W x 8Hmm | In distribution |
| 8616-5016 | SPACER MPF PEEK 8DEG 50L X 26W X 16HMM | In distribution |
| 8618-4018 | Spacer MPF PEEK 25° 40L x 22W x 18H | In distribution |
| 8618-5520 | Spacer MPF PEEK 25° 55L x 22W x 20H | In distribution |
| 8609-6045 | Screw Bicortical Ti ø6.0x45mm | In distribution |
| 8603-6010 | Spacer MPF PEEK 0° 60L x 22W x 10Hmm | In distribution |
| 8606-0300 | Cover Plate 3-Hole Ti Assy | In distribution |
| 8603-4008 | Spacer MPF PEEK 0° 40L x 22W x 8Hmm | In distribution |
| 8603-5014 | Spacer MPF PEEK 0° 50L x 22W x 14Hmm | In distribution |
| 8604-6008 | Spacer MPF PEEK 8° 60L x 22W x 8Hmm | In distribution |
| 8620-6008 | Spacer Lat PEEK Spiked 0° 60L X 22W X 08 | In distribution |
| 8621-5016 | MPF SPACER 18X50X16 14DEG ASSY | In distribution |
| 8616-4010 | SPACER MPF PEEK 8DEG 40L X 26W X 10HMM | In distribution |
| 8605-0116 | Plate Buttress 1 Hole Ti 16mm Assy | In distribution |
| 8602-4016 | Spacer MPF PEEK 8° 40L x 18W x 16Hmm | In distribution |
| 8604-4508 | Spacer MPF PEEK 8° 45L x 22W x 8Hmm | In distribution |
| 8616-4512 | SPACER MPF PEEK 8DEG 45L X 26W X 12HMM | In distribution |
| 8608-5545 | Screw Fixed Self-Tapping Ti ø5.5x45mm | In distribution |
| 8608-6045 | Screw Fixed Self-Tapping Ti ø6.0x45mm | In distribution |
| 8606-0100 | Plate Buttress 1 Hole Ti Cover Assy | In distribution |
| 8603-5016 | Spacer MPF PEEK 0° 50L x 22W x 16Hmm | In distribution |
| 8604-5514 | Spacer MPF PEEK 8° 55L x 22W x 14Hmm | In distribution |
| 8615-6010 | SPACER MPF PEEK 0DEG 60L X 26W X 10HMM | In distribution |
| 8603-4010 | Spacer MPF PEEK 0° 40L x 22W x 10Hmm | In distribution |
| 8616-5008 | SPACER MPF PEEK 8DEG 50L X 26W X 8HMM | In distribution |
| 8609-6050 | Screw Bicortical Ti ø6.0x50mm | In distribution |
| 8608-6030 | Screw Fixed Self-Tapping Ti ø6.0x30mm | In distribution |
| 8602-5008 | Spacer MPF PEEK 8° 50L x 18W x 8Hmm | In distribution |
| 8615-4508 | SPACER MPF PEEK 0DEG 45L X 26W X 8HMM | In distribution |
| 8618-5514 | Spacer MPF PEEK 25° 55L x 22W x 14H | In distribution |
| 8608-5555 | Screw Fixed Self-Tapping Ti ø5.5x55mm | In distribution |
| 8615-4514 | SPACER MPF PEEK 0DEG 45L X 26W X 14HMM | In distribution |
| 8603-5512 | Spacer MPF PEEK 0° 55L x 22W x 12Hmm | In distribution |
| 8604-6016 | Spacer MPF PEEK 8° 60L x 22W x 16Hmm | In distribution |
| 8607-5035 | Screw Self-Tapping Ti ø5.0x35mm | 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.