Timberline MPF Lateral Modular Plate Fixation System
91 catalogue numbers from 8620-5016, listed by Biomet Spine, United States, under Spinal Vertebral Body Replacement Device. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
91catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 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 |
|---|---|---|
| 8620-5016 | SPACER LAT PEEK SPIKED 0° 50L X 22W X 16 | In distribution |
| 8607-6065 | SCREW SELF-TAPPING TI Ø6.0X65MM | In distribution |
| 8613-6012 | SPACER MPF PEEK 20° 60L X 22W X 12H | In distribution |
| 8605-0408 | PLATE 4 HOLE TI 8MM ASSY | In distribution |
| 8608-5065 | SCREW FIXED SELF-TAPPING TI Ø5.0X65MM | In distribution |
| 8603-5514 | SPACER MPF PEEK 0° 55L X 22W X 14HMM | In distribution |
| 8613-5016 | SPACER MPF PEEK 20° 50L X 22W X 16H | In distribution |
| 8606-0406 | COVER PLATE 4-HOLE TI 6MM ASSY | In distribution |
| 8613-5512 | SPACER MPF PEEK 20° 55L X 22W X 12H | In distribution |
| 8620-6014 | SPACER LAT PEEK SPIKED 0° 60L X 22W X 14 | In distribution |
| 8613-5014 | SPACER MPF PEEK 20° 50L X 22W X 14H | In distribution |
| 8620-5510 | SPACER LAT PEEK SPIKED 0° 55L X 22W X 10 | In distribution |
| 8605-0112 | PLATE BUTTRESS 1 HOLE TI 12MM ASSY | In distribution |
| 8601-4514 | SPACER MPF PEEK 0° 45L X 18W X 14HMM | In distribution |
| 8609-6065 | SCREW BICORTICAL TI Ø6.0X65MM | In distribution |
| 8604-4510 | SPACER MPF PEEK 8° 45L X 22W X 10HMM | In distribution |
| 8610-6055 | SCREW FIXED BICORTICAL TI Ø6.0X55MM | In distribution |
| 8620-0220 | TIM MPF 2 HOLE PLATE 20MM ASSY | In distribution |
| 8602-5508 | SPACER MPF PEEK 8° 55L X 18W X 8HMM | In distribution |
| 8609-5065 | SCREW BICORTICAL TI Ø5.0X65MM | In distribution |
| 8604-4512 | SPACER MPF PEEK 8° 45L X 22W X 12HMM | In distribution |
| 8608-5045 | SCREW FIXED SELF-TAPPING TI Ø5.0X45MM | In distribution |
| 8601-5514 | SPACER MPF PEEK 0° 55L X 18W X 14HMM | In distribution |
| 8604-5510 | SPACER MPF PEEK 8° 55L X 22W X 10HMM | In distribution |
| 8602-5512 | SPACER MPF PEEK 8° 55L X 18W X 12HMM | In distribution |
| 8607-5030 | SCREW SELF-TAPPING TI Ø5.0X30MM | In distribution |
| 8602-5016 | SPACER MPF PEEK 8° 50L X 18W X 16HMM | In distribution |
| 8609-5550 | SCREW BICORTICAL TI Ø5.5X50MM | In distribution |
| 8606-0400 | COVER PLATE 4-HOLE TI ASSY | In distribution |
| 8613-6016 | SPACER MPF PEEK 20° 60L X 22W X 16H | In distribution |
| 8602-5510 | SPACER MPF PEEK 8° 55L X 18W X 10HMM | In distribution |
| 8603-6016 | SPACER MPF PEEK 0° 60L X 22W X 16HMM | In distribution |
| 8601-4516 | SPACER MPF PEEK 0° 45L X 18W X 16HMM | In distribution |
| 8604-5516 | SPACER MPF PEEK 8° 55L X 22W X 16HMM | In distribution |
| 8607-6040 | SCREW SELF-TAPPING TI Ø6.0X40MM | In distribution |
| 8602-4010 | SPACER MPF PEEK 8° 40L X 18W X 10HMM | In distribution |
| 8620-4010 | SPACER LAT PEEK SPIKED 0° 40L X 22W X 10 | In distribution |
| 8608-5060 | SCREW FIXED SELF-TAPPING TI Ø5.0X60MM | In distribution |
| 8604-5008 | SPACER MPF PEEK 8° 50L X 22W X 8HMM | In distribution |
| 8601-4008 | SPACER MPF PEEK 0° 40L X 18W X 8HMM | In distribution |
| 8607-5045 | SCREW SELF-TAPPING TI Ø5.0X45MM | In distribution |
| 8609-5560 | SCREW BICORTICAL TI Ø5.5X60MM | In distribution |
| 8603-4510 | SPACER MPF PEEK 0° 45L X 22W X 10HMM | In distribution |
| 8608-5540 | SCREW FIXED SELF-TAPPING TI Ø5.5X40MM | In distribution |
| 8608-5530 | SCREW FIXED SELF-TAPPING TI Ø5.5X30MM | In distribution |
| 8608-5560 | SCREW FIXED SELF-TAPPING TI Ø5.5X60MM | In distribution |
| 8620-5014 | SPACER LAT PEEK SPIKED 0° 50L X 22W X 14 | In distribution |
| 8613-4520 | SPACER MPF PEEK 20° 45L X 22W X 20H | In distribution |
| 8605-0210 | PLATE 2 HOLE TI 10MM ASSY | In distribution |
| 8614-5518 | SPACER MPF PEEK 30° 55L X 22W X 18H | In distribution |
| 8605-0410 | PLATE 4 HOLE TI 10MM ASSY | In distribution |
| 8609-5540 | SCREW BICORTICAL TI Ø5.5X40MM | In distribution |
| 8604-5016 | SPACER MPF PEEK 8° 50L X 22W X 16HMM | In distribution |
| 8602-4014 | SPACER MPF PEEK 8° 40L X 18W X 14HMM | In distribution |
| 8620-5514 | SPACER LAT PEEK SPIKED 0° 55L X 22W X 14 | In distribution |
| 8613-4518 | SPACER MPF PEEK 20° 45L X 22W X 18H | In distribution |
| 8604-4010 | SPACER MPF PEEK 8° 40L X 22W X 10HMM | In distribution |
| 8610-5550 | SCREW FIXED BICORTICAL TI Ø5.5X50MM | In distribution |
| 8601-4512 | SPACER MPF PEEK 0° 45L X 18W X 12HMM | In distribution |
| 8606-0218 | TIM MPF 2 HOLE LG COV PLATE ASSY | 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 |
| 8620-5012 | SPACER LAT PEEK SPIKED 0° 50L X 22W X 12 | In distribution |
| 8601-5510 | SPACER MPF PEEK 0° 55L X 18W X 10HMM | In distribution |
| 8620-6016 | SPACER LAT PEEK SPIKED 0° 60L X 22W X 16 | In distribution |
| 8607-6030 | SCREW SELF-TAPPING TI Ø6.0X30MM | In distribution |
| 8620-6012 | SPACER LAT PEEK SPIKED 0° 60L X 22W X 12 | In distribution |
| 8610-5545 | SCREW FIXED BICORTICAL TI Ø5.5X45MM | In distribution |
| 8605-0014 | PLATE PLUG TI 14MM ASSY | In distribution |
| 8620-0218 | TIM MPF 2 HOLE PLATE 18MM ASSY | In distribution |
| 8605-0406 | PLATE 4 HOLE TI 6MM ASSY | In distribution |
| 8608-5565 | SCREW FIXED SELF-TAPPING TI Ø5.5X65MM | In distribution |
| 8605-0114 | PLATE BUTTRESS 1 HOLE TI 14MM ASSY | In distribution |
| 8602-6016 | SPACER MPF PEEK 8° 60L X 18W X 16HMM | In distribution |
| 8601-4016 | SPACER MPF PEEK 0° 40L X 18W X 16HMM | In distribution |
| 8604-4016 | SPACER MPF PEEK 8° 40L X 22W X 16HMM | In distribution |
| 8603-5516 | SPACER MPF PEEK 0° 55L X 22W X 16HMM | In distribution |
| 8605-0216 | PLATE 2 HOLE TI 16MM ASSY | In distribution |
| 8614-4514 | SPACER MPF PEEK 30° 45L X 22W X 14H | In distribution |
| 8614-4520 | SPACER MPF PEEK 30° 45L X 22W X 20H | In distribution |
| 8606-0118 | TIM MPF 1 HOLE LG COV PLATE ASSY | In distribution |
| 8609-5045 | SCREW BICORTICAL TI Ø5.0X45MM | In distribution |
| 8609-5060 | SCREW BICORTICAL TI Ø5.0X60MM | In distribution |
| 8613-4012 | SPACER MPF PEEK 20° 40L X 22W X 12H | In distribution |
| 8602-4508 | SPACER MPF PEEK 8° 45L X 18W X 8HMM | In distribution |
| 8605-0312 | PLATE 3 HOLE TI 12MM ASSY | In distribution |
| 8603-4012 | SPACER MPF PEEK 0° 40L X 22W X 12HMM | In distribution |
| 8620-0218 | TIM MPF 2 HOLE PLATE 18MM ASSY | In distribution |
| 8614-4020 | SPACER MPF PEEK 30° 40L X 22W X 20H | In distribution |
| 8602-4012 | SPACER MPF PEEK 8° 40L X 18W X 12HMM | In distribution |
| 8601-4010 | SPACER MPF PEEK 0° 40L X 18W X 10HMM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoRoent | Nuvasive, Inc. | 1,514 |
| Capri™ Corpectomy Cage System | VB Spine LLC | 1,509 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,189 |
| Fortify | Globus Medical, Inc. | 866 |
| Matrixx System | Nexxt Spine LLC | 748 |
| Ascend | Alphatec Spine, Inc. | 555 |
| Zavation VBR Trial | Zavation | 548 |
| Verte-Stack® Spinal System | Medtronic Sofamor Danek, Inc. | 484 |
| Timberline® Lateral Interbody Fusion System | Biomet Spine | 470 |
| Timberline Lateral Fusion System | Biomet Spine | 459 |
| Novel | Alphatec Spine, Inc. | 447 |
| Hawkeye™ Vertebral Body Replacement (VBR) | Choice Spine, LP | 368 |
Showing 12 of 683. All products under Spinal Vertebral Body Replacement Device
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K063393 | 2007-06-25 |
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.