Timberline MPF Lateral Modular Plate Fixation System
85 catalogue numbers from 8614-4018, listed by Biomet Spine, United States, under Intervertebral Fusion Device With Integrated Fixation, Lumbar. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
85catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, 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 |
|---|---|---|
| 8614-4018 | SPACER MPF PEEK 30° 40L X 22W X 18H | In distribution |
| 8610-5540 | SCREW FIXED BICORTICAL TI Ø5.5X40MM | In distribution |
| 8605-0016 | PLATE PLUG TI 16MM ASSY | In distribution |
| 8609-6045 | SCREW BICORTICAL TI Ø6.0X45MM | In distribution |
| 8607-5565 | SCREW SELF-TAPPING TI Ø5.5X65MM | In distribution |
| 8608-5535 | SCREW FIXED SELF-TAPPING TI Ø5.5X35MM | In distribution |
| 8609-5050 | SCREW BICORTICAL TI Ø5.0X50MM | In distribution |
| 8616-6008 | SPACER MPF PEEK 8DEG 60L X 26W X 8HMM | In distribution |
| 8615-5512 | SPACER MPF PEEK 0DEG 55L X 26W X 12HMM | In distribution |
| 8608-6065 | SCREW FIXED SELF-TAPPING TI Ø6.0X65MM | In distribution |
| 8602-4514 | SPACER MPF PEEK 8° 45L X 18W X 14HMM | In distribution |
| 8607-5060 | SCREW SELF-TAPPING TI Ø5.0X60MM | In distribution |
| 8607-6055 | SCREW SELF-TAPPING TI Ø6.0X55MM | In distribution |
| 8614-6020 | SPACER MPF PEEK 30° 60L X 22W X 20H | In distribution |
| 8602-4016 | SPACER MPF PEEK 8° 40L X 18W X 16HMM | In distribution |
| 8602-4512 | SPACER MPF PEEK 8° 45L X 18W X 12HMM | In distribution |
| 8609-6040 | SCREW BICORTICAL TI Ø6.0X40MM | In distribution |
| 8603-5508 | SPACER MPF PEEK 0° 55L X 22W X 8HMM | In distribution |
| 8607-6045 | SCREW SELF-TAPPING TI Ø6.0X45MM | In distribution |
| 8601-4510 | SPACER MPF PEEK 0° 45L X 18W X 10HMM | In distribution |
| 8603-4512 | SPACER MPF PEEK 0° 45L X 22W X 12HMM | In distribution |
| 8603-4516 | SPACER MPF PEEK 0° 45L X 22W X 16HMM | In distribution |
| 8605-0416 | PLATE 4 HOLE TI 16MM ASSY | In distribution |
| 8614-6018 | SPACER MPF PEEK 30° 60L X 22W X 18H | In distribution |
| 8610-5065 | SCREW FIXED BICORTICAL TI Ø5.0X65MM | In distribution |
| 8615-4508 | SPACER MPF PEEK 0DEG 45L X 26W X 8HMM | In distribution |
| 8610-6040 | SCREW FIXED BICORTICAL TI Ø6.0X40MM | In distribution |
| 8610-5565 | SCREW FIXED BICORTICAL TI Ø5.5X65MM | In distribution |
| 8615-6008 | SPACER MPF PEEK 0DEG 60L X 26W X 8HMM | In distribution |
| 8607-6060 | SCREW SELF-TAPPING TI Ø6.0X60MM | In distribution |
| 8607-5050 | SCREW SELF-TAPPING TI Ø5.0X50MM | In distribution |
| 8604-5010 | SPACER MPF PEEK 8° 50L X 22W X 10HMM | In distribution |
| 8604-5512 | SPACER MPF PEEK 8° 55L X 22W X 12HMM | In distribution |
| 8607-5545 | SCREW SELF-TAPPING TI Ø5.5X45MM | In distribution |
| 8608-5550 | SCREW FIXED SELF-TAPPING TI Ø5.5X50MM | In distribution |
| 8616-4516 | SPACER MPF PEEK 8DEG 45L X 26W X 16HMM | In distribution |
| 8615-4016 | SPACER MPF PEEK 0DEG 40L X 26W X 16HMM | In distribution |
| 8603-6008 | SPACER MPF PEEK 0° 60L X 22W X 8HMM | In distribution |
| 8607-5555 | SCREW SELF-TAPPING TI Ø5.5X55MM | In distribution |
| 8603-5012 | SPACER MPF PEEK 0° 50L X 22W X 12HMM | In distribution |
| 8608-6040 | SCREW FIXED SELF-TAPPING TI Ø6.0X40MM | In distribution |
| 8605-0110 | PLATE BUTTRESS 1 HOLE TI 10MM ASSY | In distribution |
| 8616-5510 | SPACER MPF PEEK 8DEG 55L X 26W X 10HMM | In distribution |
| 8602-5014 | SPACER MPF PEEK 8° 50L X 18W X 14HMM | In distribution |
| 8614-4518 | SPACER MPF PEEK 30° 45L X 22W X 18H | In distribution |
| 8601-5512 | SPACER MPF PEEK 0° 55L X 18W X 12HMM | In distribution |
| 8603-4508 | SPACER MPF PEEK 0° 45L X 22W X 8HMM | In distribution |
| 8604-4516 | SPACER MPF PEEK 8° 45L X 22W X 16HMM | In distribution |
| 8615-5508 | SPACER MPF PEEK 0DEG 55L X 26W X 8HMM | In distribution |
| 8614-5520 | SPACER MPF PEEK 30° 55L X 22W X 20H | In distribution |
| 8614-4014 | SPACER MPF PEEK 30° 40L X 22W X 14H | In distribution |
| 8610-5560 | SCREW FIXED BICORTICAL TI Ø5.5X60MM | In distribution |
| 8616-6010 | SPACER MPF PEEK 8DEG 60L X 26W X 10HMM | In distribution |
| 8613-4016 | SPACER MPF PEEK 20° 40L X 22W X 16H | In distribution |
| 8601-5508 | SPACER MPF PEEK 0° 55L X 18W X 8HMM | In distribution |
| 8616-4514 | SPACER MPF PEEK 8DEG 45L X 26W X 14HMM | In distribution |
| 8605-0116 | PLATE BUTTRESS 1 HOLE TI 16MM ASSY | In distribution |
| 8604-4508 | SPACER MPF PEEK 8° 45L X 22W X 8HMM | In distribution |
| 8616-5010 | SPACER MPF PEEK 8DEG 50L X 26W X 10HMM | In distribution |
| 8610-5045 | SCREW FIXED BICORTICAL TI Ø5.0X45MM | In distribution |
| 8605-0010 | PLATE PLUG TI 10MM ASSY | In distribution |
| 8609-5545 | SCREW BICORTICAL TI Ø5.5X45MM | In distribution |
| 8602-6014 | SPACER MPF PEEK 8° 60L X 18W X 14HMM | In distribution |
| 8613-5518 | SPACER MPF PEEK 20° 55L X 22W X 18H | In distribution |
| 8604-5012 | SPACER MPF PEEK 8° 50L X 22W X 12HMM | In distribution |
| 8607-5040 | SCREW SELF-TAPPING TI Ø5.0X40MM | In distribution |
| 8604-6008 | SPACER MPF PEEK 8° 60L X 22W X 8HMM | In distribution |
| 8605-0316 | PLATE 3 HOLE TI 16MM ASSY | In distribution |
| 8616-5512 | SPACER MPF PEEK 8DEG 55L X 26W X 12HMM | In distribution |
| 8616-4508 | SPACER MPF PEEK 8DEG 45L X 26W X 8HMM | In distribution |
| 8613-4020 | SPACER MPF PEEK 20° 40L X 22W X 20H | In distribution |
| 8605-0012 | PLATE PLUG TI 12MM ASSY | In distribution |
| 8604-4008 | SPACER MPF PEEK 8° 40L X 22W X 8HMM | In distribution |
| 8609-5040 | SCREW BICORTICAL TI Ø5.0X40MM | In distribution |
| 8614-5516 | SPACER MPF PEEK 30° 55L X 22W X 16H | In distribution |
| 8610-5555 | SCREW FIXED BICORTICAL TI Ø5.5X55MM | In distribution |
| 8606-0200 | COVER PLATE 2-HOLE TI ASSY | In distribution |
| 8615-4510 | SPACER MPF PEEK 0DEG 45L X 26W X 10HMM | In distribution |
| 8601-4012 | SPACER MPF PEEK 0° 40L X 18W X 12HMM | In distribution |
| 8602-6012 | SPACER MPF PEEK 8° 60L X 18W X 12HMM | In distribution |
| 8603-4014 | SPACER MPF PEEK 0° 40L X 22W X 14HMM | In distribution |
| 8610-5060 | SCREW FIXED BICORTICAL TI Ø5.0X60MM | In distribution |
| 8607-5540 | SCREW SELF-TAPPING TI Ø5.5X40MM | In distribution |
| 8615-4010 | SPACER MPF PEEK 0DEG 40L X 26W X 10HMM | In distribution |
| 8609-5565 | SCREW BICORTICAL TI Ø5.5X65MM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141791 | 2014-10-09 |
| K093629 | 2010-03-09 |
| K081501 | 2008-07-02 |
| K081395 | 2008-06-25 |
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.