Timberline® MPF Lateral Interbody Modular Plate Fixation System
95 catalogue numbers from 8614-5520, 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
95catalogue 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 | 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 |
|---|---|---|
| 8614-5520 | Spacer MPF PEEK 30° 55L x 22W x 20H | In distribution |
| 8605-0416 | Plate 4 Hole Ti 16mm Assy | In distribution |
| 8616-6014 | SPACER MPF PEEK 8DEG 60L X 26W X 14HMM | In distribution |
| 8613-5012 | Spacer MPF PEEK 20° 50L x 22W x 12H | In distribution |
| 8615-5512 | SPACER MPF PEEK 0DEG 55L X 26W X 12HMM | In distribution |
| 8604-5508 | Spacer MPF PEEK 8° 55L x 22W x 8Hmm | In distribution |
| 8607-6055 | Screw Self-Tapping Ti ø6.0x55mm | In distribution |
| 8603-6014 | Spacer MPF PEEK 0° 60L x 22W x 14Hmm | In distribution |
| 8610-5055 | Screw Fixed Bicortical Ti ø5.0x55mm | In distribution |
| 8621-5518 | MPF SPACER 18X55X18 14DEG ASSY | In distribution |
| 8622-6018 | MPF SPACER 22X60X18 14DEG ASSY | In distribution |
| 8602-5510 | Spacer MPF PEEK 8° 55L x 18W x 10Hmm | In distribution |
| 8613-4014 | Spacer MPF PEEK 20° 40L x 22W x 14H | In distribution |
| 8614-4514 | Spacer MPF PEEK 30° 45L x 22W x 14H | In distribution |
| 8621-4010 | MPF SPACER 18X40X10 14DEG ASSY | In distribution |
| 8615-5008 | SPACER MPF PEEK 0DEG 50L X 26W X 8HMM | In distribution |
| 8614-5014 | Spacer MPF PEEK 30° 50L x 22W x 14H | In distribution |
| 8622-4510 | MPF SPACER 22X45X10 14DEG ASSY | In distribution |
| 8601-6012 | Spacer MPF PEEK 0° 60L x 18W x 12Hmm | In distribution |
| 8621-5516 | MPF SPACER 18X55X16 14DEG ASSY | In distribution |
| 8607-5545 | Screw Self-Tapping Ti ø5.5x45mm | In distribution |
| 8621-6012 | MPF SPACER 18X60X12 14DEG ASSY | In distribution |
| 8616-5010 | SPACER MPF PEEK 8DEG 50L X 26W X 10HMM | 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 |
| 8622-5018 | MPF SPACER 22X50X18 14DEG ASSY | In distribution |
| 8614-5020 | Spacer MPF PEEK 30° 50L x 22W x 20H | In distribution |
| 8603-5510 | Spacer MPF PEEK 0° 55L x 22W x 10Hmm | In distribution |
| 8608-6035 | Screw Fixed Self-Tapping Ti ø6.0x35mm | In distribution |
| 8604-6012 | Spacer MPF PEEK 8° 60L x 22W x 12Hmm | In distribution |
| 8603-4512 | Spacer MPF PEEK 0° 45L x 22W x 12Hmm | In distribution |
| 8607-6045 | Screw Self-Tapping Ti ø6.0x45mm | In distribution |
| 8601-5014 | Spacer MPF PEEK 0° 50L x 18W x 14Hmm | In distribution |
| 8601-5012 | Spacer MPF PEEK 0° 50L x 18W x 12Hmm | In distribution |
| 8622-5020 | MPF SPACER 22X50X20 14DEG ASSY | In distribution |
| 8604-6014 | Spacer MPF PEEK 8° 60L x 22W x 14Hmm | In distribution |
| 8618-5516 | Spacer MPF PEEK 25° 55L x 22W x 16H | In distribution |
| 8604-4514 | Spacer MPF PEEK 8° 45L x 22W x 14Hmm | In distribution |
| 8618-4514 | Spacer MPF PEEK 25° 45L x 22W x 14H | In distribution |
| 8613-6012 | Spacer MPF PEEK 20° 60L x 22W x 12H | In distribution |
| 8607-5555 | Screw Self-Tapping Ti ø5.5x55mm | In distribution |
| 8621-6020 | MPF SPACER 18X60X20 14DEG ASSY | In distribution |
| 8618-4518 | Spacer MPF PEEK 25° 45L x 22W x 18H | In distribution |
| 8601-4014 | Spacer MPF PEEK 0° 40L x 18W x 14Hmm | In distribution |
| 8614-4520 | Spacer MPF PEEK 30° 45L x 22W x 20H | In distribution |
| 8616-6016 | SPACER MPF PEEK 8DEG 60L X 26W X 16HMM | In distribution |
| 8618-4014 | Spacer MPF PEEK 25° 40L x 22W x 14H | In distribution |
| 8622-6014 | MPF SPACER 22X60X14 14DEG ASSY | In distribution |
| 8621-4014 | MPF SPACER 18X40X14 14DEG ASSY | In distribution |
| 8607-5055 | Screw Self-Tapping Ti ø5.0x55mm | In distribution |
| 8621-4510 | MPF SPACER 18X45X10 14DEG ASSY | In distribution |
| 8605-0208 | Plate 2 Hole Ti 8mm Assy | In distribution |
| 8602-6008 | Spacer MPF PEEK 8° 60L x 18W x 8Hmm | In distribution |
| 8608-5030 | Screw Fixed Self-Tapping Ti ø5.0x30mm | In distribution |
| 8608-6050 | Screw Fixed Self-Tapping Ti ø6.0x50mm | In distribution |
| 8610-5545 | Screw Fixed Bicortical Ti ø5.5x45mm | In distribution |
| 8622-5518 | MPF SPACER 22X55X18 14DEG ASSY | In distribution |
| 8618-6020 | Spacer MPF PEEK 25° 60L x 22W x 20H | In distribution |
| 8613-4016 | Spacer MPF PEEK 20° 40L x 22W x 16H | In distribution |
| 8605-0010 | Plate Plug Ti 10mm Assy | In distribution |
| 8616-5514 | SPACER MPF PEEK 8DEG 55L X 26W X 14HMM | In distribution |
| 8614-6018 | Spacer MPF PEEK 30° 60L x 22W x 18H | In distribution |
| 8621-5514 | MPF SPACER 18X55X14 14DEG ASSY | In distribution |
| 8608-5060 | Screw Fixed Self-Tapping Ti ø5.0x60mm | In distribution |
| 8603-4012 | Spacer MPF PEEK 0° 40L x 22W x 12Hmm | In distribution |
| 8615-6014 | SPACER MPF PEEK 0DEG 60L X 26W X 14HMM | In distribution |
| 8605-0414 | Plate 4 Hole Ti 14mm Assy | In distribution |
| 8607-5045 | Screw Self-Tapping Ti ø5.0x45mm | In distribution |
| 8607-5040 | Screw Self-Tapping Ti ø5.0x40mm | In distribution |
| 8622-4520 | MPF SPACER 22X45X20 14DEG ASSY | In distribution |
| 8610-6045 | Screw Fixed Bicortical Ti ø6.0x45mm | In distribution |
| 8604-6010 | Spacer MPF PEEK 8° 60L x 22W x 10Hmm | In distribution |
| 8621-6014 | MPF SPACER 18X60X14 14DEG ASSY | In distribution |
| 8604-5512 | Spacer MPF PEEK 8° 55L x 22W x 12Hmm | In distribution |
| 8618-4516 | Spacer MPF PEEK 25° 45L x 22W x 16H | In distribution |
| 8602-5508 | Spacer MPF PEEK 8° 55L x 18W x 8Hmm | In distribution |
| 8603-6012 | Spacer MPF PEEK 0° 60L x 22W x 12Hmm | In distribution |
| 8621-5510 | MPF SPACER 18X55X10 14DEG ASSY | In distribution |
| 8622-4012 | MPF SPACER 22X40X12 14DEG ASSY | In distribution |
| 8601-5008 | Spacer MPF PEEK 0° 50L x 18W x 8Hmm | In distribution |
| 8613-4514 | Spacer MPF PEEK 20° 45L x 22W x 14H | In distribution |
| 8622-5510 | MPF SPACER 22X55X10 14DEG ASSY | In distribution |
| 8610-5045 | Screw Fixed Bicortical Ti ø5.0x45mm | In distribution |
| 8616-6010 | SPACER MPF PEEK 8DEG 60L X 26W X 10HMM | In distribution |
| 8605-0014 | Plate Plug Ti 14mm Assy | In distribution |
| 8616-6012 | SPACER MPF PEEK 8DEG 60L X 26W X 12HMM | In distribution |
| 8621-6016 | MPF SPACER 18X60X16 14DEG ASSY | In distribution |
| 8605-0108 | Plate Buttress 1 Hole Ti 8mm Assy | In distribution |
| 8621-4518 | MPF SPACER 18X45X18 14DEG ASSY | In distribution |
| 8607-6035 | Screw Self-Tapping Ti ø6.0x35mm | In distribution |
| 8610-5050 | Screw Fixed Bicortical Ti ø5.0x50mm | In distribution |
| 8618-4020 | Spacer MPF PEEK 25° 40L x 22W x 20H | In distribution |
| 8622-4016 | MPF SPACER 22X40X16 14DEG ASSY | In distribution |
| 8622-5012 | MPF SPACER 22X50X12 14DEG ASSY | In distribution |
| 8622-4516 | MPF SPACER 22X45X16 14DEG ASSY | 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.