Spinal Fixation System
87 catalogue numbers from 7701-6160, listed by Biomet Spine, United States, under Orthosis, Spinal Pedicle Fixation. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
87catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spinal Pedicle Fixation
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Record published | 2015-10-24 |
| Record revised | 2025-07-02 (version 6) |
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 |
|---|---|---|
| 7701-6160 | ROD STRAIGHT COCR Ø5.5X160MM | In distribution |
| 7701-6080 | ROD STRAIGHT COCR Ø5.5X80MM | In distribution |
| 7715-4520 | PEDICLE SCREW TI Ø4.5X20MM | In distribution |
| 7707-6020 | ROD STRAIGHT COCR MATTE Ø 5.5 X 20 MM | In distribution |
| 7715-7570 | PEDICLE SCREW TI Ø7.5X70MM | In distribution |
| 7701-6020 | ROD STRAIGHT COCR Ø5.5X20MM | In distribution |
| 7715-8555 | PEDICLE SCREW TI Ø8.5X55MM | In distribution |
| 7701-6500 | ROD STRAIGHT COCR Ø5.5X500MM | In distribution |
| 7707-6200 | ROD STRAIGHT COCR MATTE Ø 5.5 X 200 MM | In distribution |
| 7715-6560 | PEDICLE SCREW TI Ø6.5X60MM | In distribution |
| 7701-6025 | ROD STRAIGHT COCR Ø5.5X25MM | In distribution |
| 7701-5065 | ROD MEDIUM CURVED TI Ø5.5X65MM | In distribution |
| 7701-6110 | ROD STRAIGHT COCR Ø5.5X110MM | In distribution |
| 7701-7045 | ROD CURVED COCR Ø5.5X45MM | In distribution |
| 7707-5070 | ROD MED CURVED COCR MATTE Ø 5.5 X 70 MM | In distribution |
| 7715-5545 | PEDICLE SCREW TI Ø5.5X45MM | In distribution |
| 7701-7065 | ROD CURVED COCR Ø5.5X65MM | In distribution |
| 7707-5190 | ROD MED CURVED COCR MATTE Ø 5.5 X 190 MM | In distribution |
| 7701-0065 | ROD STRAIGHT TI Ø5.5X65MM | In distribution |
| 7701-0045 | ROD STRAIGHT TI Ø5.5X45MM | In distribution |
| 7707-5180 | ROD MED CURVED COCR MATTE Ø 5.5 X 180 MM | In distribution |
| 7707-5050 | ROD MED CURVED COCR MATTE Ø 5.5 X 50 MM | In distribution |
| 7701-5035 | ROD MEDIUM CURVED TI Ø5.5X35MM | In distribution |
| 7707-6085 | ROD STRAIGHT COCR MATTE Ø 5.5 X 85 MM | In distribution |
| 7701-7055 | ROD CURVED COCR Ø5.5X55MM | In distribution |
| 7701-5100 | ROD MEDIUM CURVED TI Ø5.5X100MM | In distribution |
| 7707-5045 | ROD MED CURVED COCR MATTE Ø 5.5 X 45 MM | In distribution |
| 7707-7050 | ROD CURVED COCR MATTE Ø 5.5 X 50 MM | In distribution |
| 7701-0600 | ROD RIGID HEX TIP DEFORMITY TI 600MM | In distribution |
| 7701-0130 | ROD STRAIGHT TI Ø5.5X130MM | In distribution |
| 7701-1025 | ROD CURVED TI Ø5.5X25MM | In distribution |
| 7701-5045 | ROD MEDIUM CURVED TI Ø5.5X45MM | In distribution |
| 7701-5160 | ROD MEDIUM CURVED TI Ø5.5X160MM | In distribution |
| 7707-5035 | ROD MED CURVED COCR MATTE Ø 5.5 X 35 MM | In distribution |
| 7707-6055 | ROD STRAIGHT COCR MATTE Ø 5.5 X 55 MM | In distribution |
| 7715-6530 | PEDICLE SCREW TI Ø6.5X30MM | In distribution |
| 7707-5105 | ROD MED CURVED COCR MATTE Ø 5.5 X 105 MM | In distribution |
| 7707-6025 | ROD STRAIGHT COCR MATTE Ø 5.5 X 25 MM | In distribution |
| 7701-7035 | ROD CURVED COCR Ø5.5X35MM | In distribution |
| 7707-5085 | ROD MED CURVED COCR MATTE Ø 5.5 X 85 MM | In distribution |
| 7701-7120 | ROD CURVED COCR Ø5.5X120MM | In distribution |
| 7701-0200 | ROD STRAIGHT TI Ø5.5X200MM | In distribution |
| 7701-0500 | ROD RIGID HEX TIP DEFORMITY TI 500MM | In distribution |
| 7701-6100 | ROD STRAIGHT COCR Ø5.5X100MM | In distribution |
| 7701-5150 | ROD MEDIUM CURVED TI Ø5.5X150MM | In distribution |
| 7701-5080 | ROD MEDIUM CURVED TI Ø5.5X80MM | In distribution |
| 7701-0150 | ROD STRAIGHT TI Ø5.5X150MM | In distribution |
| 7715-7535 | PEDICLE SCREW TI Ø7.5X35MM | In distribution |
| 7707-7055 | ROD CURVED COCR MATTE Ø 5.5 X 55 MM | In distribution |
| 7715-4540 | PEDICLE SCREW TI Ø4.5X40MM | In distribution |
| 7701-5110 | ROD MEDIUM CURVED TI Ø5.5X110MM | In distribution |
| 7707-6090 | ROD STRAIGHT COCR MATTE Ø 5.5 X 90 MM | In distribution |
| 7715-7560 | PEDICLE SCREW TI Ø7.5X60MM | In distribution |
| 7707-7080 | ROD CURVED COCR MATTE Ø 5.5 X 80 MM | In distribution |
| 7715-6550 | PEDICLE SCREW TI Ø6.5X50MM | In distribution |
| 7715-6525 | PEDICLE SCREW TI Ø6.5X25MM | In distribution |
| 7701-7115 | ROD CURVED COCR Ø5.5X115MM | In distribution |
| 7707-5065 | ROD MED CURVED COCR MATTE Ø 5.5 X 65 MM | In distribution |
| 7707-6050 | ROD STRAIGHT COCR MATTE Ø 5.5 X 50 MM | In distribution |
| 7701-6200 | ROD STRAIGHT COCR Ø5.5X200MM | In distribution |
| 7707-6070 | ROD STRAIGHT COCR MATTE Ø 5.5 X 70 MM | In distribution |
| 7701-6120 | ROD STRAIGHT COCR Ø5.5X120MM | In distribution |
| 7701-7105 | ROD CURVED COCR Ø5.5X105MM | In distribution |
| 7701-0105 | ROD STRAIGHT TI Ø5.5X105MM | In distribution |
| 7701-6095 | ROD STRAIGHT COCR Ø5.5X95MM | In distribution |
| 7715-4545 | PEDICLE SCREW TI Ø4.5X45MM | In distribution |
| 7701-0025 | ROD STRAIGHT TI Ø5.5X25MM | In distribution |
| 7701-6170 | ROD STRAIGHT COCR Ø5.5X170MM | In distribution |
| 7715-4560 | PEDICLE SCREW TI Ø4.5X60MM | In distribution |
| 7707-6100 | ROD STRAIGHT COCR MATTE Ø 5.5 X 100 MM | In distribution |
| 7701-7030 | ROD CURVED COCR Ø5.5X30MM | In distribution |
| 7707-7095 | ROD CURVED COCR MATTE Ø 5.5 X 95 MM | In distribution |
| 7701-7075 | ROD CURVED COCR Ø5.5X75MM | In distribution |
| 7707-6180 | ROD STRAIGHT COCR MATTE Ø 5.5 X 180 MM | In distribution |
| 7707-6110 | ROD STRAIGHT COCR MATTE Ø 5.5 X 110 MM | In distribution |
| 7701-5070 | ROD MEDIUM CURVED TI Ø5.5X70MM | In distribution |
| 7701-6045 | ROD STRAIGHT COCR Ø5.5X45MM | In distribution |
| 7701-0140 | ROD STRAIGHT TI Ø5.5X140MM | In distribution |
| 7715-5540 | PEDICLE SCREW TI Ø5.5X40MM | In distribution |
| 7701-7070 | ROD CURVED COCR Ø5.5X70MM | In distribution |
| 7701-5180 | ROD MEDIUM CURVED TI Ø5.5X180MM | In distribution |
| 7715-5570 | PEDICLE SCREW TI Ø5.5X70MM | In distribution |
| 7701-6070 | ROD STRAIGHT COCR Ø5.5X70MM | In distribution |
| 7701-0090 | ROD STRAIGHT TI Ø5.5X90MM | In distribution |
| 7715-7520 | PEDICLE SCREW TI Ø7.5X20MM | In distribution |
| 7707-6035 | ROD STRAIGHT COCR MATTE Ø 5.5 X 35 MM | In distribution |
| 7701-6115 | ROD STRAIGHT COCR Ø5.5X115MM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
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.