Spinal Fixation System
62 catalogue numbers from 7707-5055, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Interlaminal. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
62catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| 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 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| 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 |
|---|---|---|
| 7707-5055 | ROD MED CURVED COCR MATTE Ø 5.5 X 55 MM | In distribution |
| 7707-5110 | ROD MED CURVED COCR MATTE Ø 5.5 X 110 MM | In distribution |
| 7715-5550 | PEDICLE SCREW TI Ø5.5X50MM | In distribution |
| 7707-5140 | ROD MED CURVED COCR MATTE Ø 5.5 X 140 MM | In distribution |
| 7707-6115 | ROD STRAIGHT COCR MATTE Ø 5.5 X 115 MM | In distribution |
| 7701-6090 | ROD STRAIGHT COCR Ø5.5X90MM | In distribution |
| 7701-6085 | ROD STRAIGHT COCR Ø5.5X85MM | In distribution |
| 7701-6130 | ROD STRAIGHT COCR Ø5.5X130MM | In distribution |
| 7707-6125 | ROD STRAIGHT COCR MATTE Ø 5.5 X 125 MM | In distribution |
| 7701-7090 | ROD CURVED COCR Ø5.5X90MM | In distribution |
| 7715-4530 | PEDICLE SCREW TI Ø4.5X30MM | In distribution |
| 7715-6580 | PEDICLE SCREW TI Ø6.5X80MM | In distribution |
| 7701-7095 | ROD CURVED COCR Ø5.5X95MM | In distribution |
| 7701-0040 | ROD STRAIGHT TI Ø5.5X40MM | In distribution |
| 7701-6050 | ROD STRAIGHT COCR Ø5.5X50MM | In distribution |
| 7701-6150 | ROD STRAIGHT COCR Ø5.5X150MM | In distribution |
| 7707-6040 | ROD STRAIGHT COCR MATTE Ø 5.5 X 40 MM | In distribution |
| 7701-1040 | ROD CURVED TI Ø5.5X40MM | In distribution |
| 7701-0060 | ROD STRAIGHT TI Ø5.5X60MM | In distribution |
| 7701-1080 | ROD CURVED TI Ø5.5X80MM | In distribution |
| 7707-6190 | ROD STRAIGHT COCR MATTE Ø 5.5 X 190 MM | In distribution |
| 7701-5125 | ROD MEDIUM CURVED TI Ø5.5X125MM | In distribution |
| 7715-8550 | PEDICLE SCREW TI Ø8.5X50MM | In distribution |
| 7715-8545 | PEDICLE SCREW TI Ø8.5X45MM | In distribution |
| 7701-7085 | ROD CURVED COCR Ø5.5X85MM | In distribution |
| 7701-5055 | ROD MEDIUM CURVED TI Ø5.5X55MM | In distribution |
| 7701-5200 | ROD MEDIUM CURVED TI Ø5.5X200MM | In distribution |
| 7701-1065 | ROD CURVED TI Ø5.5X65MM | In distribution |
| 7715-7540 | PEDICLE SCREW TI Ø7.5X40MM | In distribution |
| 7707-7085 | ROD CURVED COCR MATTE Ø 5.5 X 85 MM | In distribution |
| 7707-5040 | ROD MED CURVED COCR MATTE Ø 5.5 X 40 MM | In distribution |
| 7701-5025 | ROD MEDIUM CURVED TI Ø5.5X25MM | In distribution |
| 7701-5140 | ROD MEDIUM CURVED TI Ø5.5X140MM | In distribution |
| 7707-5080 | ROD MED CURVED COCR MATTE Ø 5.5 X 80 MM | In distribution |
| 7701-7025 | ROD CURVED COCR Ø5.5X25MM | In distribution |
| 7701-1070 | ROD CURVED TI Ø5.5X70MM | In distribution |
| 7701-5095 | ROD MEDIUM CURVED TI Ø5.5X95MM | In distribution |
| 7701-6035 | ROD STRAIGHT COCR Ø5.5X35MM | In distribution |
| 7715-8540 | PEDICLE SCREW TI Ø8.5X40MM | In distribution |
| 7701-5175 | ROD MEDIUM CURVED TI Ø5.5X175MM | In distribution |
| 7707-6105 | ROD STRAIGHT COCR MATTE Ø 5.5 X 105 MM | In distribution |
| 7715-4555 | PEDICLE SCREW TI Ø4.5X55MM | In distribution |
| 7707-7105 | ROD CURVED COCR MATTE Ø 5.5 X 105 MM | In distribution |
| 7701-6190 | ROD STRAIGHT COCR Ø5.5X190MM | In distribution |
| 7707-7065 | ROD CURVED COCR MATTE Ø 5.5 X 65 MM | In distribution |
| 7707-5030 | ROD MED CURVED COCR MATTE Ø 5.5 X 30 MM | In distribution |
| 7701-7060 | ROD CURVED COCR Ø5.5X60MM | In distribution |
| 7715-8535 | PEDICLE SCREW TI Ø8.5X35MM | In distribution |
| 7701-7080 | ROD CURVED COCR Ø5.5X80MM | In distribution |
| 7701-5020 | ROD MEDIUM CURVED TI Ø5.5X20MM | In distribution |
| 7701-6060 | ROD STRAIGHT COCR Ø5.5X60MM | In distribution |
| 7701-7020 | ROD CURVED COCR Ø5.5X20MM | In distribution |
| 7707-5115 | ROD MED CURVED COCR MATTE Ø 5.5 X 115 MM | In distribution |
| 7701-6300 | ROD STRAIGHT COCR Ø5.5X300MM | In distribution |
| 7703-1600 | SET SCREW 5.5MM ROD TI | In distribution |
| 7701-6065 | ROD STRAIGHT COCR Ø5.5X65MM | In distribution |
| 7701-0170 | ROD STRAIGHT TI Ø5.5X170MM | In distribution |
| 7701-0190 | ROD STRAIGHT TI Ø5.5X190MM | In distribution |
| 7701-0030 | ROD STRAIGHT TI Ø5.5X30MM | In distribution |
| 7707-7115 | ROD CURVED COCR MATTE Ø 5.5 X 115 MM | In distribution |
| 7701-0120 | ROD STRAIGHT TI Ø5.5X120MM | In distribution |
| 7701-6140 | ROD STRAIGHT COCR Ø5.5X140MM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K071377 | 2007-08-06 |
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.