Timberline® MPF Lateral Interbody Modular Plate Fixation System
92 catalogue numbers from 8622-5520, 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
92catalogue 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 | 2017-06-22 |
| 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 |
|---|---|---|
| 8622-5520 | MPF SPACER 22X55X20 14DEG ASSY | In distribution |
| 8622-4010 | MPF SPACER 22X40X10 14DEG ASSY | In distribution |
| 8622-5512 | MPF SPACER 22X55X12 14DEG ASSY | In distribution |
| 8620-4014 | Spacer Lat PEEK Spiked 0° 40L X 22W X 14 | In distribution |
| 8614-6020 | Spacer MPF PEEK 30° 60L x 22W x 20H | In distribution |
| 8604-4510 | Spacer MPF PEEK 8° 45L x 22W x 10Hmm | In distribution |
| 8605-0210 | Plate 2 Hole Ti 10mm Assy | In distribution |
| 8613-5512 | Spacer MPF PEEK 20° 55L x 22W x 12H | In distribution |
| 8607-5050 | Screw Self-Tapping Ti ø5.0x50mm | In distribution |
| 8622-6020 | MPF SPACER 22X60X20 14DEG ASSY | In distribution |
| 8621-5010 | MPF SPACER 18X50X10 14DEG ASSY | In distribution |
| 8601-4008 | Spacer MPF PEEK 0° 40L x 18W x 8Hmm | In distribution |
| 8601-4016 | Spacer MPF PEEK 0° 40L x 18W x 16Hmm | In distribution |
| 8613-4516 | Spacer MPF PEEK 20° 45L x 22W x 16H | In distribution |
| 8609-6055 | Screw Bicortical Ti ø6.0x55mm | In distribution |
| 8609-5540 | Screw Bicortical Ti ø5.5x40mm | In distribution |
| 8606-0200 | Cover Plate 2-Hole Ti Assy | In distribution |
| 8603-5012 | Spacer MPF PEEK 0° 50L x 22W x 12Hmm | In distribution |
| 8603-4014 | Spacer MPF PEEK 0° 40L x 22W x 14Hmm | In distribution |
| 8622-6010 | MPF SPACER 22X60X10 14DEG ASSY | In distribution |
| 8613-5520 | Spacer MPF PEEK 20° 55L x 22W x 20H | In distribution |
| 8609-5040 | Screw Bicortical Ti ø5.0x40mm | In distribution |
| 8609-5560 | Screw Bicortical Ti ø5.5x60mm | In distribution |
| 8605-0308 | Plate 3 Hole Ti 8mm Assy | In distribution |
| 8602-4516 | Spacer MPF PEEK 8° 45L x 18W x 16Hmm | In distribution |
| 8621-5012 | MPF SPACER 18X50X12 14DEG ASSY | In distribution |
| 8602-4014 | Spacer MPF PEEK 8° 40L x 18W x 14Hmm | In distribution |
| 8620-4016 | Spacer Lat PEEK Spiked 0° 40L X 22W X 16 | In distribution |
| 8621-5512 | MPF SPACER 18X55X12 14DEG ASSY | In distribution |
| 8620-5510 | Spacer Lat PEEK Spiked 0° 55L X 22W X 10 | In distribution |
| 8607-5030 | Screw Self-Tapping Ti ø5.0x30mm | In distribution |
| 8608-6060 | Screw Fixed Self-Tapping Ti ø6.0x60mm | In distribution |
| 8608-5050 | Screw Fixed Self-Tapping Ti ø5.0x50mm | In distribution |
| 8622-5516 | MPF SPACER 22X55X16 14DEG ASSY | In distribution |
| 8613-5018 | Spacer MPF PEEK 20° 50L x 22W x 18H | In distribution |
| 8620-4512 | Spacer Lat PEEK Spiked 0° 45L X 22W X 12 | In distribution |
| 8610-5040 | Screw Fixed Bicortical Ti ø5.0x40mm | In distribution |
| 8622-4014 | MPF SPACER 22X40X14 14DEG ASSY | In distribution |
| 8601-5010 | Spacer MPF PEEK 0° 50L x 18W x 10Hmm | In distribution |
| 8620-5512 | Spacer Lat PEEK Spiked 0° 55L X 22W X 12 | In distribution |
| 8601-6014 | Spacer MPF PEEK 0° 60L x 18W x 14Hmm | In distribution |
| 8621-4016 | MPF SPACER 18X40X16 14DEG ASSY | In distribution |
| 8605-0216 | Plate 2 Hole Ti 16mm Assy | In distribution |
| 8607-5535 | Screw Self-Tapping Ti ø5.5x35mm | In distribution |
| 8621-6010 | MPF SPACER 18X60X10 14DEG ASSY | In distribution |
| 8616-6018 | SPACER MPF PEEK 8° 60L X 26W X 18HMM | In distribution |
| 8603-4514 | Spacer MPF PEEK 0° 45L x 22W x 14Hmm | In distribution |
| 8621-4018 | MPF SPACER 18X40X18 14DEG ASSY | In distribution |
| 8605-0312 | Plate 3 Hole Ti 12mm Assy | In distribution |
| 8601-4010 | Spacer MPF PEEK 0° 40L x 18W x 10Hmm | In distribution |
| 8603-5514 | Spacer MPF PEEK 0° 55L x 22W x 14Hmm | In distribution |
| 8622-4018 | MPF SPACER 22X40X18 14DEG ASSY | In distribution |
| 8620-4508 | Spacer Lat PEEK Spiked 0° 45L X 22W X 08 | In distribution |
| 8618-6018 | SPACER MPF PEEK 25° 60L X 22W | In distribution |
| 8602-5514 | Spacer MPF PEEK 8° 55L x 18W x 14Hmm | In distribution |
| 8620-4516 | Spacer Lat PEEK Spiked 0° 45L X 22W X 16 | In distribution |
| 8621-4512 | MPF SPACER 18X45X12 14DEG ASSY | In distribution |
| 8614-6014 | Spacer MPF PEEK 30° 60L x 22W x 14H | In distribution |
| 8620-5016 | Spacer Lat PEEK Spiked 0° 50L X 22W X 16 | In distribution |
| 8613-6018 | Spacer MPF PEEK 20° 60L x 22W x 18H | In distribution |
| 8613-5516 | Spacer MPF PEEK 20° 55L x 22W x 16H | In distribution |
| 8607-5530 | Screw Self-Tapping Ti ø5.5x30mm | In distribution |
| 8621-5020 | MPF SPACER 18X50X20 14DEG ASSY | In distribution |
| 8622-4512 | MPF SPACER 22X45X12 14DEG ASSY | In distribution |
| 8620-6016 | Spacer Lat PEEK Spiked 0° 60L X 22W X 16 | In distribution |
| 8602-5014 | Spacer MPF PEEK 8° 50L x 18W x 14Hmm | In distribution |
| 8609-5550 | Screw Bicortical Ti ø5.5x50mm | In distribution |
| 8602-4512 | Spacer MPF PEEK 8° 45L x 18W x 12Hmm | In distribution |
| 8622-6016 | MPF SPACER 22X60X16 14DEG ASSY | In distribution |
| 8613-4520 | Spacer MPF PEEK 20° 45L x 22W x 20H | In distribution |
| 8604-4012 | Spacer MPF PEEK 8° 40L x 22W x 12Hmm | In distribution |
| 8622-5514 | MPF SPACER 22X55X14 14DEG ASSY | In distribution |
| 8621-5018 | MPF SPACER 18X50X18 14DEG ASSY | In distribution |
| 8601-4514 | Spacer MPF PEEK 0° 45L x 18W x 14Hmm | In distribution |
| 8603-4016 | Spacer MPF PEEK 0° 40L x 22W x 16Hmm | In distribution |
| 8601-5514 | Spacer MPF PEEK 0° 55L x 18W x 14Hmm | In distribution |
| 8620-6014 | Spacer Lat PEEK Spiked 0° 60L X 22W X 14 | In distribution |
| 8604-4016 | Spacer MPF PEEK 8° 40L x 22W x 16Hmm | In distribution |
| 8620-4510 | Spacer Lat PEEK Spiked 0° 45L X 22W X 10 | In distribution |
| 8609-5045 | Screw Bicortical Ti ø5.0x45mm | In distribution |
| 8607-5060 | Screw Self-Tapping Ti ø5.0x60mm | In distribution |
| 8608-5045 | Screw Fixed Self-Tapping Ti ø5.0x45mm | In distribution |
| 8602-5516 | Spacer MPF PEEK 8° 55L x 18W x 16Hmm | In distribution |
| 8613-4012 | Spacer MPF PEEK 20° 40L x 22W x 12H | In distribution |
| 8608-5550 | Screw Fixed Self-Tapping Ti ø5.5x50mm | In distribution |
| 8607-5560 | Screw Self-Tapping Ti ø5.5x60mm | In distribution |
| 8605-0114 | Plate Buttress 1 Hole Ti 14mm Assy | In distribution |
| 8621-4520 | MPF SPACER 18X45X20 14DEG ASSY | In distribution |
| 8620-4514 | Spacer Lat PEEK Spiked 0° 45L X 22W X 14 | In distribution |
| 8620-5516 | Spacer Lat PEEK Spiked 0° 55L X 22W X 16 | In distribution |
| 8620-4010 | Spacer Lat PEEK Spiked 0° 40L X 22W X 10 | In distribution |
| 8620-5514 | Spacer Lat PEEK Spiked 0° 55L X 22W X 14 | 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.