Timberline MPF Lateral Modular Plate Fixation System
Spacer MPF Peek 0DEG 60L X 26W X 16HMM
3manufacturers in China registered for this device type
350catalogue numbers in this listing
5recalls on this 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 | Highridge Medical, LLC, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2025-12-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8605-0406 | Device Size Text, specify—Plate 4 Hole Ti 6mm Assy | In distribution |
| 8603-4516 | Device Size Text, specify—Spacer MPF PEEK 0° 45L x 22W x 16Hmm | In distribution |
| 8607-6035 | Device Size Text, specify—Screw Self-Tapping Ti ø6.0x35mm | In distribution |
| 8613-5014 | In distribution | |
| 8605-0416 | Device Size Text, specify—Plate 4 Hole Ti 16mm Assy | In distribution |
| 8605-0414 | Device Size Text, specify—Plate 4 Hole Ti 14mm Assy | In distribution |
| 8601-5008 | Device Size Text, specify—Spacer MPF PEEK 0° 50L x 18W x 8Hmm | In distribution |
| 8620-0118 | Device Size Text, specify—TIM MPF 1 HOLE PLATE 18MM ASSY | In distribution |
| 8601-4508 | Device Size Text, specify—Spacer MPF PEEK 0° 45L x 18W x 8Hmm | In distribution |
| 8604-5516 | Device Size Text, specify—Spacer MPF PEEK 8° 55L x 22W x 16Hmm | In distribution |
| 8607-6040 | Device Size Text, specify—Screw Self-Tapping Ti ø6.0x40mm | In distribution |
| 8603-5512 | Device Size Text, specify—Spacer MPF PEEK 0° 55L x 22W x 12Hmm | In distribution |
| 8603-4016 | Device Size Text, specify—Spacer MPF PEEK 0° 40L x 22W x 16Hmm | In distribution |
| 8607-5550 | Device Size Text, specify—Screw Self-Tapping Ti ø5.5x50mm | In distribution |
| 8604-6010 | Device Size Text, specify—Spacer MPF PEEK 8° 60L x 22W x 10Hmm | In distribution |
| 8601-6010 | Device Size Text, specify—Spacer MPF PEEK 0° 60L x 18W x 10Hmm | In distribution |
| 8604-5010 | Device Size Text, specify—Spacer MPF PEEK 8° 50L x 22W x 10Hmm | In distribution |
| 8604-4014 | Device Size Text, specify—Spacer MPF PEEK 8° 40L x 22W x 14Hmm | In distribution |
| 8609-5050 | Device Size Text, specify—Screw Bicortical Ti ø5.0x50mm | In distribution |
| 8602-6008 | Device Size Text, specify—Spacer MPF PEEK 8° 60L x 18W x 8Hmm | In distribution |
| 8606-0100 | In distribution | |
| 8614-6020 | In distribution | |
| 8622-6016 | Device Size Text, specify—MPF SPACER 22X60X16 14DEG ASSY | In distribution |
| 8622-4010 | Device Size Text, specify—MPF SPACER 22X40X10 14DEG ASSY | In distribution |
| 8621-6010 | Device Size Text, specify—MPF SPACER 18X60X10 14DEG ASSY | In distribution |
| 8604-6008 | Device Size Text, specify—Spacer MPF PEEK 8° 60L x 22W x 8Hmm | In distribution |
| 8605-0108 | In distribution | |
| 8616-4508 | Device Size Text, specify—SPACER MPF PEEK 8DEG 45L X 26W X 8HMM | In distribution |
| 8613-4514 | In distribution | |
| 8603-6008 | Device Size Text, specify—Spacer MPF PEEK 0° 60L x 22W x 8Hmm | In distribution |
| 8608-5530 | Device Size Text, specify—Screw Fixed Self-Tapping Ti ø5.5x30mm | In distribution |
| 8605-0314 | Device Size Text, specify—Plate 3 Hole Ti 14mm Assy | In distribution |
| 8605-0208 | Device Size Text, specify—Plate 2 Hole Ti 8mm Assy | In distribution |
| 8621-4014 | Device Size Text, specify—MPF SPACER 18X40X14 14DEG ASSY | In distribution |
| 8613-5016 | In distribution | |
| 8604-4514 | Device Size Text, specify—Spacer MPF PEEK 8° 45L x 22W x 14Hmm | In distribution |
| 8602-4008 | Device Size Text, specify—Spacer MPF PEEK 8° 40L x 18W x 8Hmm | In distribution |
| 8610-5040 | Device Size Text, specify—Screw Fixed Bicortical Ti ø5.0x40mm | In distribution |
| 8605-0016 | Device Size Text, specify—Plate Plug Ti 16mm Assy | In distribution |
| 8615-6016 | Device Size Text, specify—SPACER MPF PEEK 0DEG 60L X 26W X 16HMM | In distribution |
| 8608-5545 | Device Size Text, specify—Screw Fixed Self-Tapping Ti ø5.5x45mm | In distribution |
| 8601-4012 | Device Size Text, specify—Spacer MPF PEEK 0° 40L x 18W x 12Hmm | In distribution |
| 8606-0218 | Device Size Text, specify—TIM MPF 2 HOLE LG COV PLATE ASSY | In distribution |
| 8621-5514 | Device Size Text, specify—MPF SPACER 18X55X14 14DEG ASSY | In distribution |
| 8615-5514 | Device Size Text, specify—SPACER MPF PEEK 0DEG 55L X 26W X 14HMM | In distribution |
| 8604-4010 | Device Size Text, specify—Spacer MPF PEEK 8° 40L x 22W x 10Hmm | In distribution |
| 8615-5510 | Device Size Text, specify—SPACER MPF PEEK 0DEG 55L X 26W X 10HMM | In distribution |
| 8604-4508 | Device Size Text, specify—Spacer MPF PEEK 8° 45L x 22W x 8Hmm | In distribution |
| 8601-6012 | Device Size Text, specify—Spacer MPF PEEK 0° 60L x 18W x 12Hmm | In distribution |
| 8604-4016 | Device Size Text, specify—Spacer MPF PEEK 8° 40L x 22W x 16Hmm | In distribution |
| 8602-4508 | Device Size Text, specify—Spacer MPF PEEK 8° 45L x 18W x 8Hmm | In distribution |
| 8621-6020 | Device Size Text, specify—MPF SPACER 18X60X20 14DEG ASSY | In distribution |
| 8622-6010 | Device Size Text, specify—MPF SPACER 22X60X10 14DEG ASSY | In distribution |
| 8601-5510 | Device Size Text, specify—Spacer MPF PEEK 0° 55L x 18W x 10Hmm | In distribution |
| 8604-5514 | Device Size Text, specify—Spacer MPF PEEK 8° 55L x 22W x 14Hmm | In distribution |
| 8608-6050 | Device Size Text, specify—Screw Fixed Self-Tapping Ti ø6.0x50mm | In distribution |
| 8622-5516 | Device Size Text, specify—MPF SPACER 22X55X16 14DEG ASSY | In distribution |
| 8608-5535 | Device Size Text, specify—Screw Fixed Self-Tapping Ti ø5.5x35mm | In distribution |
| 8602-5016 | Device Size Text, specify—Spacer MPF PEEK 8° 50L x 18W x 16Hmm | In distribution |
| 8604-5008 | Device Size Text, specify—Spacer MPF PEEK 8° 50L x 22W x 8Hmm | In distribution |
| 8621-4512 | Device Size Text, specify—MPF SPACER 18X45X12 14DEG ASSY | In distribution |
| 8616-6014 | Device Size Text, specify—SPACER MPF PEEK 8DEG 60L X 26W X 14HMM | In distribution |
| 8616-5512 | Device Size Text, specify—SPACER MPF PEEK 8DEG 55L X 26W X 12HMM | In distribution |
| 8609-6045 | Device Size Text, specify—Screw Bicortical Ti ø6.0x45mm | In distribution |
| 8607-5055 | Device Size Text, specify—Screw Self-Tapping Ti ø5.0x55mm | In distribution |
| 8603-5012 | Device Size Text, specify—Spacer MPF PEEK 0° 50L x 22W x 12Hmm | In distribution |
| 8614-5514 | In distribution | |
| 8622-4016 | Device Size Text, specify—MPF SPACER 22X40X16 14DEG ASSY | In distribution |
| 8605-0310 | Device Size Text, specify—Plate 3 Hole Ti 10mm Assy | In distribution |
| 8613-4512 | In distribution | |
| 8606-0400 | Device Size Text, specify—Cover Plate 4-Hole Ti Assy | In distribution |
| 8620-0120 | Device Size Text, specify—TIM MPF 1 HOLE PLATE 20MM ASSY | In distribution |
| 8614-4514 | In distribution | |
| 8602-4014 | Device Size Text, specify—Spacer MPF PEEK 8° 40L x 18W x 14Hmm | In distribution |
| 8602-5516 | Device Size Text, specify—Spacer MPF PEEK 8° 55L x 18W x 16Hmm | In distribution |
| 8603-5508 | Device Size Text, specify—Spacer MPF PEEK 0° 55L x 22W x 8Hmm | In distribution |
| 8622-6018 | Device Size Text, specify—MPF SPACER 22X60X18 14DEG ASSY | In distribution |
| 8622-5010 | Device Size Text, specify—MPF SPACER 22X50X10 14DEG ASSY | In distribution |
| 8607-6030 | Device Size Text, specify—Screw Self-Tapping Ti ø6.0x30mm | In distribution |
| 8601-5014 | Device Size Text, specify—Spacer MPF PEEK 0° 50L x 18W x 14Hmm | In distribution |
| 8613-5512 | In distribution | |
| 8622-5020 | Device Size Text, specify—MPF SPACER 22X50X20 14DEG ASSY | In distribution |
| 8604-6016 | Device Size Text, specify—Spacer MPF PEEK 8° 60L x 22W x 16Hmm | In distribution |
| 8603-4012 | Device Size Text, specify—Spacer MPF PEEK 0° 40L x 22W x 12Hmm | In distribution |
| 8609-5545 | Device Size Text, specify—Screw Bicortical Ti ø5.5x45mm | In distribution |
| 8608-6040 | Device Size Text, specify—Screw Fixed Self-Tapping Ti ø6.0x40mm | In distribution |
| 8621-5018 | Device Size Text, specify—MPF SPACER 18X50X18 14DEG ASSY | In distribution |
| 8616-4516 | Device Size Text, specify—SPACER MPF PEEK 8DEG 45L X 26W X 16HMM | In distribution |
| 8615-5508 | Device Size Text, specify—SPACER MPF PEEK 0DEG 55L X 26W X 8HMM | In distribution |
| 8604-5016 | Device Size Text, specify—Spacer MPF PEEK 8° 50L x 22W x 16Hmm | In distribution |
| 8608-5045 | Device Size Text, specify—Screw Fixed Self-Tapping Ti ø5.0x45mm | In distribution |
| 8622-4020 | Device Size Text, specify—MPF SPACER 22X40X20 14DEG ASSY | In distribution |
| 8616-5510 | Device Size Text, specify—SPACER MPF PEEK 8DEG 55L X 26W X 10HMM | In distribution |
| 8604-6012 | Device Size Text, specify—Spacer MPF PEEK 8° 60L x 22W x 12Hmm | In distribution |
| 8615-6012 | Device Size Text, specify—SPACER MPF PEEK 0DEG 60L X 26W X 12HMM | In distribution |
| 8601-5012 | Device Size Text, specify—Spacer MPF PEEK 0° 50L x 18W x 12Hmm | In distribution |
| 8607-5560 | Device Size Text, specify—Screw Self-Tapping Ti ø5.5x60mm | In distribution |
| 8604-4512 | Device Size Text, specify—Spacer MPF PEEK 8° 45L x 22W x 12Hmm | In distribution |
| 8605-0312 | Device Size Text, specify—Plate 3 Hole Ti 12mm Assy | In distribution |
| 8622-4520 | Device Size Text, specify—MPF SPACER 22X45X20 14DEG ASSY | In distribution |
| 8605-0308 | Device Size Text, specify—Plate 3 Hole Ti 8mm Assy | In distribution |
| 8603-5514 | Device Size Text, specify—Spacer MPF PEEK 0° 55L x 22W x 14Hmm | In distribution |
| 8602-6014 | Device Size Text, specify—Spacer MPF PEEK 8° 60L x 18W x 14Hmm | In distribution |
| 8601-6008 | Device Size Text, specify—Spacer MPF PEEK 0° 60L x 18W x 8Hmm | In distribution |
| 8605-0214 | Device Size Text, specify—Plate 2 Hole Ti 14mm Assy | In distribution |
| 8616-6008 | Device Size Text, specify—SPACER MPF PEEK 8DEG 60L X 26W X 8HMM | In distribution |
| 8602-4010 | Device Size Text, specify—Spacer MPF PEEK 8° 40L x 18W x 10Hmm | In distribution |
| 8610-5045 | Device Size Text, specify—Screw Fixed Bicortical Ti ø5.0x45mm | In distribution |
| 8610-5545 | Device Size Text, specify—Screw Fixed Bicortical Ti ø5.5x45mm | In distribution |
| 8616-6012 | Device Size Text, specify—SPACER MPF PEEK 8DEG 60L X 26W X 12HMM | In distribution |
| 8607-6045 | Device Size Text, specify—Screw Self-Tapping Ti ø6.0x45mm | In distribution |
| 8621-4012 | Device Size Text, specify—MPF SPACER 18X40X12 14DEG ASSY | In distribution |
| 8607-5535 | Device Size Text, specify—Screw Self-Tapping Ti ø5.5x35mm | In distribution |
| 8602-4514 | Device Size Text, specify—Spacer MPF PEEK 8° 45L x 18W x 14Hmm | In distribution |
| 8605-0316 | Device Size Text, specify—Plate 3 Hole Ti 16mm Assy | In distribution |
| 8613-4518 | In distribution | |
| 8603-6010 | Device Size Text, specify—Spacer MPF PEEK 0° 60L x 22W x 10Hmm | In distribution |
| 8613-4516 | In distribution | |
| 8609-5540 | Device Size Text, specify—Screw Bicortical Ti ø5.5x40mm | In distribution |
| 8601-4016 | Device Size Text, specify—Spacer MPF PEEK 0° 40L x 18W x 16Hmm | In distribution |
| 8621-5516 | Device Size Text, specify—MPF SPACER 18X55X16 14DEG ASSY | In distribution |
| 8601-4010 | Device Size Text, specify—Spacer MPF PEEK 0° 40L x 18W x 10Hmm | In distribution |
| 8614-4520 | In distribution | |
| 8602-5510 | Device Size Text, specify—Spacer MPF PEEK 8° 55L x 18W x 10Hmm | In distribution |
| 8610-5055 | Device Size Text, specify—Screw Fixed Bicortical Ti ø5.0x55mm | In distribution |
| 8605-0114 | In distribution | |
| 8622-5014 | Device Size Text, specify—MPF SPACER 22X50X14 14DEG ASSY | In distribution |
| 8614-5520 | In distribution | |
| 8621-5010 | Device Size Text, specify—MPF SPACER 18X50X10 14DEG ASSY | In distribution |
| 8615-4516 | Device Size Text, specify—SPACER MPF PEEK 0DEG 45L X 26W X 16HMM | In distribution |
| 8615-6010 | Device Size Text, specify—SPACER MPF PEEK 0DEG 60L X 26W X 10HMM | In distribution |
| 8608-6035 | Device Size Text, specify—Screw Fixed Self-Tapping Ti ø6.0x35mm | In distribution |
| 8616-4512 | Device Size Text, specify—SPACER MPF PEEK 8DEG 45L X 26W X 12HMM | In distribution |
| 8607-5555 | Device Size Text, specify—Screw Self-Tapping Ti ø5.5x55mm | In distribution |
| 8621-5510 | Device Size Text, specify—MPF SPACER 18X55X10 14DEG ASSY | In distribution |
| 8607-5540 | Device Size Text, specify—Screw Self-Tapping Ti ø5.5x40mm | In distribution |
| 8601-5508 | Device Size Text, specify—Spacer MPF PEEK 0° 55L x 18W x 8Hmm | In distribution |
| 8605-0008 | Device Size Text, specify—Plate Plug Ti 8mm Assy | In distribution |
| 8609-6060 | Device Size Text, specify—Screw Bicortical Ti ø6.0x60mm | In distribution |
| 8607-5060 | Device Size Text, specify—Screw Self-Tapping Ti ø5.0x60mm | In distribution |
| 8605-0216 | Device Size Text, specify—Plate 2 Hole Ti 16mm Assy | In distribution |
| 8615-5014 | Device Size Text, specify—SPACER MPF PEEK 0DEG 50L X 26W X 14HMM | In distribution |
| 8607-5035 | Device Size Text, specify—Screw Self-Tapping Ti ø5.0x35mm | In distribution |
| 8604-6014 | Device Size Text, specify—Spacer MPF PEEK 8° 60L x 22W x 14Hmm | In distribution |
| 8603-4508 | Device Size Text, specify—Spacer MPF PEEK 0° 45L x 22W x 8Hmm | In distribution |
| 8615-5512 | Device Size Text, specify—SPACER MPF PEEK 0DEG 55L X 26W X 12HMM | In distribution |
| 8622-4518 | Device Size Text, specify—MPF SPACER 22X45X18 14DEG ASSY | In distribution |
| 8609-5040 | Device Size Text, specify—Screw Bicortical Ti ø5.0x40mm | In distribution |
| 8601-4014 | Device Size Text, specify—Spacer MPF PEEK 0° 40L x 18W x 14Hmm | In distribution |
| 8621-4514 | Device Size Text, specify—MPF SPACER 18X45X14 14DEG ASSY | In distribution |
| 8610-6040 | Device Size Text, specify—Screw Fixed Bicortical Ti ø6.0x40mm | In distribution |
| 8615-5008 | Device Size Text, specify—SPACER MPF PEEK 0DEG 50L X 26W X 8HMM | In distribution |
| 8616-6016 | Device Size Text, specify—SPACER MPF PEEK 8DEG 60L X 26W X 16HMM | In distribution |
| 8622-4510 | Device Size Text, specify—MPF SPACER 22X45X10 14DEG ASSY | In distribution |
| 8610-6055 | Device Size Text, specify—Screw Fixed Bicortical Ti ø6.0x55mm | In distribution |
| 8601-4008 | Device Size Text, specify—Spacer MPF PEEK 0° 40L x 18W x 8Hmm | In distribution |
| 8613-6014 | In distribution | |
| 8621-5518 | Device Size Text, specify—MPF SPACER 18X55X18 14DEG ASSY | In distribution |
| 8604-4510 | Device Size Text, specify—Spacer MPF PEEK 8° 45L x 22W x 10Hmm | In distribution |
| 8601-5016 | Device Size Text, specify—Spacer MPF PEEK 0° 50L x 18W x 16Hmm | In distribution |
| 8604-5512 | Device Size Text, specify—Spacer MPF PEEK 8° 55L x 22W x 12Hmm | In distribution |
| 8609-6055 | Device Size Text, specify—Screw Bicortical Ti ø6.0x55mm | In distribution |
| 8608-6030 | Device Size Text, specify—Screw Fixed Self-Tapping Ti ø6.0x30mm | In distribution |
| 8610-5050 | Device Size Text, specify—Screw Fixed Bicortical Ti ø5.0x50mm | In distribution |
| 8603-4014 | Device Size Text, specify—Spacer MPF PEEK 0° 40L x 22W x 14Hmm | In distribution |
| 8607-6060 | Device Size Text, specify—Screw Self-Tapping Ti ø6.0x60mm | In distribution |
| 8603-4510 | Device Size Text, specify—Spacer MPF PEEK 0° 45L x 22W x 10Hmm | In distribution |
| 8609-5055 | Device Size Text, specify—Screw Bicortical Ti ø5.0x55mm | In distribution |
| 8601-5514 | Device Size Text, specify—Spacer MPF PEEK 0° 55L x 18W x 14Hmm | In distribution |
| 8613-5020 | Device Size Text, specify—Spacer MPF PEEK 20° 50L x 22W x 20H | In distribution |
| 8621-5012 | Device Size Text, specify—MPF SPACER 18X50X12 14DEG ASSY | In distribution |
| 8613-5012 | In distribution | |
| 8604-4008 | Device Size Text, specify—Spacer MPF PEEK 8° 40L x 22W x 8Hmm | In distribution |
| 8621-5520 | Device Size Text, specify—MPF SPACER 18X55X20 14DEG ASSY | In distribution |
| 8601-6016 | Device Size Text, specify—Spacer MPF PEEK 0° 60L x 18W x 16Hmm | In distribution |
| 8604-5014 | Device Size Text, specify—Spacer MPF PEEK 8° 50L x 22W x 14Hmm | In distribution |
| 8608-5555 | Device Size Text, specify—Screw Fixed Self-Tapping Ti ø5.5x55mm | In distribution |
| 8614-4516 | In distribution | |
| 8602-4016 | Device Size Text, specify—Spacer MPF PEEK 8° 40L x 18W x 16Hmm | In distribution |
| 8605-0116 | In distribution | |
| 8609-6040 | Device Size Text, specify—Screw Bicortical Ti ø6.0x40mm | In distribution |
| 8622-4012 | Device Size Text, specify—MPF SPACER 22X40X12 14DEG ASSY | In distribution |
| 8601-6014 | Device Size Text, specify—Spacer MPF PEEK 0° 60L x 18W x 14Hmm | In distribution |
| 8607-6050 | Device Size Text, specify—Screw Self-Tapping Ti ø6.0x50mm | In distribution |
| 8604-5510 | Device Size Text, specify—Spacer MPF PEEK 8° 55L x 22W x 10Hmm | In distribution |
| 8604-5012 | Device Size Text, specify—Spacer MPF PEEK 8° 50L x 22W x 12Hmm | In distribution |
| 8609-5045 | Device Size Text, specify—Screw Bicortical Ti ø5.0x45mm | In distribution |
| 8622-5518 | Device Size Text, specify—MPF SPACER 22X55X18 14DEG ASSY | In distribution |
| 8602-4510 | Device Size Text, specify—Spacer MPF PEEK 8° 45L x 18W x 10Hmm | In distribution |
| 8622-6014 | Device Size Text, specify—MPF SPACER 22X60X14 14DEG ASSY | In distribution |
| 8622-6020 | Device Size Text, specify—MPF SPACER 22X60X20 14DEG ASSY | In distribution |
| 8601-4512 | Device Size Text, specify—Spacer MPF PEEK 0° 45L x 18W x 12Hmm | In distribution |
| 8616-4010 | Device Size Text, specify—SPACER MPF PEEK 8DEG 40L X 26W X 10HMM | In distribution |
| 8616-6010 | Device Size Text, specify—SPACER MPF PEEK 8DEG 60L X 26W X 10HMM | In distribution |
| 8605-0212 | Device Size Text, specify—Plate 2 Hole Ti 12mm Assy | In distribution |
| 8621-4018 | Device Size Text, specify—MPF SPACER 18X40X18 14DEG ASSY | In distribution |
| 8602-4516 | Device Size Text, specify—Spacer MPF PEEK 8° 45L x 18W x 16Hmm | In distribution |
| 8603-4010 | Device Size Text, specify—Spacer MPF PEEK 0° 40L x 22W x 10Hmm | In distribution |
| 8621-4516 | Device Size Text, specify—MPF SPACER 18X45X16 14DEG ASSY | In distribution |
| 8609-5560 | Device Size Text, specify—Screw Bicortical Ti ø5.5x60mm | In distribution |
| 8603-5510 | Device Size Text, specify—Spacer MPF PEEK 0° 55L x 22W x 10Hmm | In distribution |
| 8621-6018 | Device Size Text, specify—MPF SPACER 18X60X18 14DEG ASSY | In distribution |
| 8607-5050 | Device Size Text, specify—Screw Self-Tapping Ti ø5.0x50mm | In distribution |
| 8607-6055 | Device Size Text, specify—Screw Self-Tapping Ti ø6.0x55mm | In distribution |
| 8602-6010 | Device Size Text, specify—Spacer MPF PEEK 8° 60L x 18W x 10Hmm | In distribution |
| 8615-4512 | Device Size Text, specify—SPACER MPF PEEK 0DEG 45L X 26W X 12HMM | In distribution |
| 8605-0010 | Device Size Text, specify—Plate Plug Ti 10mm Assy | In distribution |
| 8621-4510 | Device Size Text, specify—MPF SPACER 18X45X10 14DEG ASSY | In distribution |
| 8614-5020 | In distribution | |
| 8610-5560 | Device Size Text, specify—Screw Fixed Bicortical Ti ø5.5x60mm | In distribution |
| 8603-5010 | Device Size Text, specify—Spacer MPF PEEK 0° 50L x 22W x 10Hmm | In distribution |
| 8605-0112 | In distribution | |
| 8614-5518 | In distribution | |
| 8607-5040 | Device Size Text, specify—Screw Self-Tapping Ti ø5.0x40mm | In distribution |
| 8615-6014 | Device Size Text, specify—SPACER MPF PEEK 0DEG 60L X 26W X 14HMM | In distribution |
| 8622-4516 | Device Size Text, specify—MPF SPACER 22X45X16 14DEG ASSY | In distribution |
| 8603-4008 | Device Size Text, specify—Spacer MPF PEEK 0° 40L x 22W x 8Hmm | In distribution |
| 8603-6016 | Device Size Text, specify—Spacer MPF PEEK 0° 60L x 22W x 16Hmm | In distribution |
| 8608-5540 | Device Size Text, specify—Screw Fixed Self-Tapping Ti ø5.5x40mm | In distribution |
| 8615-5516 | Device Size Text, specify—SPACER MPF PEEK 0DEG 55L X 26W X 16HMM | In distribution |
| 8602-5008 | Device Size Text, specify—Spacer MPF PEEK 8° 50L x 18W x 8Hmm | In distribution |
| 8603-5014 | Device Size Text, specify—Spacer MPF PEEK 0° 50L x 22W x 14Hmm | In distribution |
| 8608-5035 | Device Size Text, specify—Screw Fixed Self-Tapping Ti ø5.0x35mm | In distribution |
| 8609-5550 | Device Size Text, specify—Screw Bicortical Ti ø5.5x50mm | In distribution |
| 8616-5516 | Device Size Text, specify—SPACER MPF PEEK 8DEG 55L X 26W X 16HMM | In distribution |
| 8614-5014 | In distribution | |
| 8608-5030 | Device Size Text, specify—Screw Fixed Self-Tapping Ti ø5.0x30mm | In distribution |
| 8615-4514 | Device Size Text, specify—SPACER MPF PEEK 0DEG 45L X 26W X 14HMM | In distribution |
| 8622-5512 | Device Size Text, specify—MPF SPACER 22X55X12 14DEG ASSY | In distribution |
| 8608-5055 | Device Size Text, specify—Screw Fixed Self-Tapping Ti ø5.0x55mm | In distribution |
| 8603-5516 | Device Size Text, specify—Spacer MPF PEEK 0° 55L x 22W x 16Hmm | In distribution |
| 8622-5520 | Device Size Text, specify—MPF SPACER 22X55X20 14DEG ASSY | In distribution |
| 8622-4014 | Device Size Text, specify—MPF SPACER 22X40X14 14DEG ASSY | In distribution |
| 8621-6012 | Device Size Text, specify—MPF SPACER 18X60X12 14DEG ASSY | In distribution |
| 8601-4510 | Device Size Text, specify—Spacer MPF PEEK 0° 45L x 18W x 10Hmm | In distribution |
| 8605-0412 | Device Size Text, specify—Plate 4 Hole Ti 12mm Assy | In distribution |
| 8602-5508 | Device Size Text, specify—Spacer MPF PEEK 8° 55L x 18W x 8Hmm | In distribution |
| 8603-5016 | Device Size Text, specify—Spacer MPF PEEK 0° 50L x 22W x 16Hmm | In distribution |
| 8622-4512 | Device Size Text, specify—MPF SPACER 22X45X12 14DEG ASSY | In distribution |
| 8605-0110 | In distribution | |
| 8610-5540 | Device Size Text, specify—Screw Fixed Bicortical Ti ø5.5x40mm | In distribution |
| 8603-4512 | Device Size Text, specify—Spacer MPF PEEK 0° 45L x 22W x 12Hmm | In distribution |
| 8621-4520 | Device Size Text, specify—MPF SPACER 18X45X20 14DEG ASSY | In distribution |
| 8605-0410 | Device Size Text, specify—Plate 4 Hole Ti 10mm Assy | In distribution |
| 8616-5508 | Device Size Text, specify—SPACER MPF PEEK 8DEG 55L X 26W X 8HMM | In distribution |
| 8608-5050 | Device Size Text, specify—Screw Fixed Self-Tapping Ti ø5.0x50mm | In distribution |
| 8602-5010 | Device Size Text, specify—Spacer MPF PEEK 8° 50L x 18W x 10Hmm | In distribution |
| 8622-6012 | Device Size Text, specify—MPF SPACER 22X60X12 14DEG ASSY | In distribution |
| 8621-5020 | Device Size Text, specify—MPF SPACER 18X50X20 14DEG ASSY | In distribution |
| 8614-5516 | In distribution |
Showing 250 of 300 catalogue numbers.
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
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-02-12 | Class II | Mixed-up of materials/components | Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mislabeled lordotic angle of 12degrees when the angle is actually 6 degrees. | 10 | 2016-05-10 |
| 2013-11-04 | Class II | Process control | Lanx, Inc. is recalling various lots of Timberline MPF Straight Split Tip Driver – Short (“Driver”) because the width of the most distal end from the Driver handle (the tip of the hex portion of the Driver) is oversized. | 25 units | 2015-12-29 |
| 2013-08-22 | Class II | Component design/selection | The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the Drill into the Fixed or Variable Sleeve Assembly. | 15 | 2015-03-13 |
| 2013-08-22 | Class II | Component design/selection | The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve shaft. | 12 units | 2015-03-13 |
| 2013-08-22 | Class II | Device Design | The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve. | 14 units | 2015-03-13 |
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.