Timberline MPF Lateral Modular Plate Fixation System
81 catalogue numbers from 8603-4016, 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
81catalogue 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 | 2015-10-24 |
| Record revised | 2025-07-02 (version 7) |
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 |
|---|---|---|
| 8603-4016 | SPACER MPF PEEK 0° 40L X 22W X 16HMM | In distribution |
| 8609-5555 | SCREW BICORTICAL TI Ø5.5X55MM | In distribution |
| 8613-5520 | SPACER MPF PEEK 20° 55L X 22W X 20H | In distribution |
| 8602-4510 | SPACER MPF PEEK 8° 45L X 18W X 10HMM | In distribution |
| 8608-5050 | SCREW FIXED SELF-TAPPING TI Ø5.0X50MM | In distribution |
| 8604-6010 | SPACER MPF PEEK 8° 60L X 22W X 10HMM | In distribution |
| 8603-4010 | SPACER MPF PEEK 0° 40L X 22W X 10HMM | In distribution |
| 8620-4014 | SPACER LAT PEEK SPIKED 0° 40L X 22W X 14 | In distribution |
| 8614-5014 | SPACER MPF PEEK 30° 50L X 22W X 14H | In distribution |
| 8620-5508 | SPACER LAT PEEK SPIKED 0° 55L X 22W X 08 | In distribution |
| 8615-6010 | SPACER MPF PEEK 0DEG 60L X 26W X 10HMM | In distribution |
| 8608-6050 | SCREW FIXED SELF-TAPPING TI Ø6.0X50MM | In distribution |
| 8608-5040 | SCREW FIXED SELF-TAPPING TI Ø5.0X40MM | In distribution |
| 8620-5008 | SPACER LAT PEEK SPIKED 0° 50L X 22W X 08 | In distribution |
| 8613-5516 | SPACER MPF PEEK 20° 55L X 22W X 16H | In distribution |
| 8607-6035 | SCREW SELF-TAPPING TI Ø6.0X35MM | In distribution |
| 8610-6065 | SCREW FIXED BICORTICAL TI Ø6.0X65MM | In distribution |
| 8620-4516 | SPACER LAT PEEK SPIKED 0° 45L X 22W X 16 | In distribution |
| 8607-5065 | SCREW SELF-TAPPING TI Ø5.0X65MM | In distribution |
| 8613-4512 | SPACER MPF PEEK 20° 45L X 22W X 12H | In distribution |
| 8614-6016 | SPACER MPF PEEK 30° 60L X 22W X 16H | In distribution |
| 8613-6018 | SPACER MPF PEEK 20° 60L X 22W X 18H | In distribution |
| 8616-5516 | SPACER MPF PEEK 8DEG 55L X 26W X 16HMM | In distribution |
| 8603-6014 | SPACER MPF PEEK 0° 60L X 22W X 14HMM | In distribution |
| 8620-5516 | SPACER LAT PEEK SPIKED 0° 55L X 22W X 16 | In distribution |
| 8604-6014 | SPACER MPF PEEK 8° 60L X 22W X 14HMM | In distribution |
| 8610-5050 | SCREW FIXED BICORTICAL TI Ø5.0X50MM | In distribution |
| 8620-6008 | SPACER LAT PEEK SPIKED 0° 60L X 22W X 08 | In distribution |
| 8604-4514 | SPACER MPF PEEK 8° 45L X 22W X 14HMM | In distribution |
| 8602-4008 | SPACER MPF PEEK 8° 40L X 18W X 8HMM | In distribution |
| 8616-4012 | SPACER MPF PEEK 8DEG 40L X 26W X 12HMM | In distribution |
| 8608-5555 | SCREW FIXED SELF-TAPPING TI Ø5.5X55MM | In distribution |
| 8603-5512 | SPACER MPF PEEK 0° 55L X 22W X 12HMM | In distribution |
| 8615-4012 | SPACER MPF PEEK 0DEG 40L X 26W X 12HMM | In distribution |
| 8620-4016 | SPACER LAT PEEK SPIKED 0° 40L X 22W X 16 | In distribution |
| 8615-5514 | SPACER MPF PEEK 0DEG 55L X 26W X 14HMM | In distribution |
| 8605-0310 | PLATE 3 HOLE TI 10MM ASSY | In distribution |
| 8607-5535 | SCREW SELF-TAPPING TI Ø5.5X35MM | In distribution |
| 8610-5040 | SCREW FIXED BICORTICAL TI Ø5.0X40MM | In distribution |
| 8620-4508 | SPACER LAT PEEK SPIKED 0° 45L X 22W X 08 | In distribution |
| 8606-0218 | TIM MPF 2 HOLE LG COV PLATE ASSY | In distribution |
| 8605-0308 | PLATE 3 HOLE TI 8MM ASSY | In distribution |
| 8620-4512 | SPACER LAT PEEK SPIKED 0° 45L X 22W X 12 | In distribution |
| 8620-5010 | SPACER LAT PEEK SPIKED 0° 50L X 22W X 10 | In distribution |
| 8615-4512 | SPACER MPF PEEK 0DEG 45L X 26W X 12HMM | In distribution |
| 8603-5016 | SPACER MPF PEEK 0° 50L X 22W X 16HMM | In distribution |
| 8604-4012 | SPACER MPF PEEK 8° 40L X 22W X 12HMM | In distribution |
| 8609-6060 | SCREW BICORTICAL TI Ø6.0X60MM | In distribution |
| 8620-6010 | SPACER LAT PEEK SPIKED 0° 60L X 22W X 10 | In distribution |
| 8610-6045 | SCREW FIXED BICORTICAL TI Ø6.0X45MM | In distribution |
| 8608-5055 | SCREW FIXED SELF-TAPPING TI Ø5.0X55MM | In distribution |
| 8616-6012 | SPACER MPF PEEK 8DEG 60L X 26W X 12HMM | In distribution |
| 8620-4012 | SPACER LAT PEEK SPIKED 0° 40L X 22W X 12 | In distribution |
| 8603-4514 | SPACER MPF PEEK 0° 45L X 22W X 14HMM | In distribution |
| 8615-6012 | SPACER MPF PEEK 0DEG 60L X 26W X 12HMM | In distribution |
| 8614-5020 | SPACER MPF PEEK 30° 50L X 22W X 20H | In distribution |
| 8620-4514 | SPACER LAT PEEK SPIKED 0° 45L X 22W X 14 | In distribution |
| 8609-5055 | SCREW BICORTICAL TI Ø5.0X55MM | In distribution |
| 8614-4516 | SPACER MPF PEEK 30° 45L X 22W X 16H | In distribution |
| 8615-4008 | SPACER MPF PEEK 0DEG 40L X 26W X 8HMM | In distribution |
| 8616-5508 | SPACER MPF PEEK 8DEG 55L X 26W X 8HMM | In distribution |
| 8620-5512 | SPACER LAT PEEK SPIKED 0° 55L X 22W X 12 | In distribution |
| 8604-5014 | SPACER MPF PEEK 8° 50L X 22W X 14HMM | In distribution |
| 8606-0118 | TIM MPF 1 HOLE LG COV PLATE ASSY | In distribution |
| 8613-5514 | SPACER MPF PEEK 20° 55L X 22W X 14H | In distribution |
| 8605-0212 | PLATE 2 HOLE TI 12MM ASSY | In distribution |
| 8614-5514 | SPACER MPF PEEK 30° 55L X 22W X 14H | In distribution |
| 8602-5514 | SPACER MPF PEEK 8° 55L X 18W X 14HMM | In distribution |
| 8608-5035 | SCREW FIXED SELF-TAPPING TI Ø5.0X35MM | In distribution |
| 8613-6014 | SPACER MPF PEEK 20° 60L X 22W X 14H | In distribution |
| 8616-5016 | SPACER MPF PEEK 8DEG 50L X 26W X 16HMM | In distribution |
| 8603-5010 | SPACER MPF PEEK 0° 50L X 22W X 10HMM | In distribution |
| 8620-0118 | TIM MPF 1 HOLE PLATE 18MM ASSY | In distribution |
| 8610-6060 | SCREW FIXED BICORTICAL TI Ø6.0X60MM | In distribution |
| 8602-5008 | SPACER MPF PEEK 8° 50L X 18W X 8HMM | In distribution |
| 8603-5510 | SPACER MPF PEEK 0° 55L X 22W X 10HMM | In distribution |
| 8603-6012 | SPACER MPF PEEK 0° 60L X 22W X 12HMM | In distribution |
| 8620-4510 | SPACER LAT PEEK SPIKED 0° 45L X 22W X 10 | In distribution |
| 8620-0120 | TIM MPF 1 HOLE PLATE 20MM ASSY | In distribution |
| 8602-4516 | SPACER MPF PEEK 8° 45L X 18W X 16HMM | In distribution |
| 8620-4008 | SPACER LAT PEEK SPIKED 0° 40L X 22W X 08 | 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.