Astra Spine System
ASTRA Side-by-Side Connector, Open, Side-Loading, fitting 5.5, 6mm, and 6+H1808.35mm - 12mm Offset
13manufacturers in China registered for this device type
786catalogue 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 | Spinecraft LLC, United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2016-08-12 |
| Record revised | 2024-09-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Distribution end date | 2024-09-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A5R-60L-100 | In distribution | |
| A5R-60L-040 | In distribution | |
| A5R-60F-060K | In distribution | |
| A5M-8560R-C | In distribution | |
| A5P-6550R | In distribution | |
| A5P-7570 | In distribution | |
| A5H-L95 | In distribution | |
| A5M-8555-C | In distribution | |
| A5U-5525 | In distribution | |
| A5PSAI-85110 | In distribution | |
| A5M-5045R-C | In distribution | |
| A5P-9545R-C | In distribution | |
| A5R-55C85-325 | In distribution | |
| A5U-7040R | In distribution | |
| A5P-9530E-C | In distribution | |
| A5R-60AL-080 | In distribution | |
| A5R-60C55-325 | In distribution | |
| A5P-5555-C | In distribution | |
| A5M-5580R-C | In distribution | |
| A5R-60AL-055 | In distribution | |
| A5P-5055R-C | In distribution | |
| A5P-5555R | In distribution | |
| A5U-5030R | In distribution | |
| A5P-7550 | In distribution | |
| A5P-5070R-C | In distribution | |
| A5P-7560E-C | In distribution | |
| A5P-7070R | In distribution | |
| A5P-9535-C | In distribution | |
| A5P-5550E-C | In distribution | |
| A5R-55-325K | In distribution | |
| A5R-60F-050K | In distribution | |
| A5M-9525-C | In distribution | |
| A5M-5530 | In distribution | |
| A5R-55F-100 | In distribution | |
| A5M-5570 | In distribution | |
| A5R-60FY-045 | In distribution | |
| A5R-55-300D | In distribution | |
| A5R-55FL-090K | In distribution | |
| A5M-5060R | In distribution | |
| A5U-6035-C | In distribution | |
| A5R-55FY-090K | In distribution | |
| A5R-60FY-055 | In distribution | |
| A5M-6035-C | In distribution | |
| A5P-5570 | In distribution | |
| A5R-60C85-300K | In distribution | |
| A5M-5030R | In distribution | |
| A5RR-Z60-300K | In distribution | |
| A5RR-Z60-150K | In distribution | |
| A5P-4550-C | In distribution | |
| A5P-7030R | In distribution | |
| A5P-6035 | In distribution | |
| A5U-5535R-C | In distribution | |
| A5X-A2527 | In distribution | |
| A5R-60C70-325 | In distribution | |
| A5P-8525E-C | In distribution | |
| A5P-9580-C | In distribution | |
| A5P-4525 | In distribution | |
| A5P-5530-C | In distribution | |
| A5P-6080E-C | In distribution | |
| A5R-55FY-060 | In distribution | |
| A5RR-Z55-150K | In distribution | |
| A5P-6035-C | In distribution | |
| A5R-60C85-325 | In distribution | |
| A5M-9555 | In distribution | |
| A5R-60FY-040K | In distribution | |
| A5P-6040-C | In distribution | |
| A5P-4525E-C | In distribution | |
| A5M-5035 | In distribution | |
| 5500-CR325D | In distribution | |
| A5M-9540R | In distribution | |
| A5PSAI-95110 | In distribution | |
| A5P-6570-C | In distribution | |
| A5P-5030 | In distribution | |
| A5P-9570R-C | In distribution | |
| A5R-60H-450 | In distribution | |
| A5P-7540R-C | In distribution | |
| A5P-7025 | In distribution | |
| A5R-60FY-075 | In distribution | |
| A5R-60FY-070 | In distribution | |
| A5P-8550 | In distribution | |
| A5R-60F-030 | In distribution | |
| A5M-9550 | In distribution | |
| A5P-6530E-C | In distribution | |
| A5R-60F-120 | In distribution | |
| A5M-8540R-C | In distribution | |
| A5U-6040-C | In distribution | |
| A5R-55FY-110K | In distribution | |
| A5P-5540R-C | In distribution | |
| A5R-55F-085 | In distribution | |
| A5R-60FY-050 | In distribution | |
| A5R-60FY-200K | In distribution | |
| A5U-5580 | In distribution | |
| A5M-5060 | In distribution | |
| A5P-9590-C | In distribution | |
| A5P-5570R-C | In distribution | |
| A5R-60L-110K | In distribution | |
| A5P-9590R-C | In distribution | |
| A5P-7530R-C | In distribution | |
| A5W-O | In distribution | |
| A5R-55H-300 | In distribution | |
| A5M-9545 | In distribution | |
| A5M-95100R-C | In distribution | |
| A5P-8550R-C | In distribution | |
| A5R-60FY-085K | In distribution | |
| A5M-6080 | In distribution | |
| A5L-OT450 | In distribution | |
| A5M-70100R-C | In distribution | |
| A5M-7540R | In distribution | |
| A5P-9555E-C | In distribution | |
| A5R-60L-050K | In distribution | |
| A5R-60-450 | In distribution | |
| A5U-6560 | In distribution | |
| A6L-OTL150 | In distribution | |
| A5U-5555-C | In distribution | |
| A5R-60F-025 | In distribution | |
| A5U-4525-C | In distribution | |
| A5P-6550R-C | In distribution | |
| A5M-7080-C | In distribution | |
| A5M-6055-C | In distribution | |
| A5P-8580R-C | In distribution | |
| A5R-55FY-045 | In distribution | |
| A5M-5570R | In distribution | |
| A5L-OT035 | In distribution | |
| A5M-7550R | In distribution | |
| A5P-5530E-C | In distribution | |
| A5P-7080R-C | In distribution | |
| A5U-6570R | In distribution | |
| A5M-95100R | In distribution | |
| A5P-7050R | In distribution | |
| A5P-4530-C | In distribution | |
| A5PSAI-8590 | In distribution | |
| A5P-9570R | In distribution | |
| A5R-60F-035K | In distribution | |
| A5RR-56L-450 | In distribution | |
| A5H-RTP90 | In distribution | |
| A5M-7070-C | In distribution | |
| A5R-55FL-025 | In distribution | |
| A5U-5055-C | In distribution | |
| A5U-5030-C | In distribution | |
| A5U-5060R | In distribution | |
| A5R-60F-200K | In distribution | |
| A5P-6070R | In distribution | |
| A5U-5530R-C | In distribution | |
| A5P-4570-C | In distribution | |
| A5P-5045E-C | In distribution | |
| A5M-8555R-C | In distribution | |
| A5P-8560R-C | In distribution | |
| A5P-7570R-C | In distribution | |
| A5P-9570E-C | In distribution | |
| A5R-60-100 | In distribution | |
| A5P-5550R | In distribution | |
| A5R-60C85-300 | In distribution | |
| A5P-5030R | In distribution | |
| A5R-55C70-325K | In distribution | |
| A5S-T22C | In distribution | |
| A5P-8550-C | In distribution | |
| A5M-7530 | In distribution | |
| A5U-7090R-C | In distribution | |
| A5M-9530R-C | In distribution | |
| A5R-55C85-600K | In distribution | |
| A5R-60-060K | In distribution | |
| A5M-6080R-C | In distribution | |
| A5P-95100-C | In distribution | |
| A5U-4530R-C | In distribution | |
| A5U-4555R-C | In distribution | |
| A5M-5050R-C | In distribution | |
| A5R-60F-040K | In distribution | |
| A5M-4545-C | In distribution | |
| A5H-15RO50 | In distribution | |
| A5M-5550-C | In distribution | |
| A5M-7055-C | In distribution | |
| A5M-4540 | In distribution | |
| A5R-60FL-050K | In distribution | |
| A5M-6070R | In distribution | |
| A5R-60FY-025K | In distribution | |
| A5U-7060-C | In distribution | |
| A5M-6045 | In distribution | |
| A5R-60FY-055K | In distribution | |
| A5R-60FL-040 | In distribution | |
| A5P-6050R-C | In distribution | |
| A5R-55F-080K | In distribution | |
| A5H-15RO95 | In distribution | |
| A5M-8590R | In distribution | |
| A5P-6535-C | In distribution | |
| A5M-4535R-C | In distribution | |
| A5P-9525R-C | In distribution | |
| A5M-75100-C | In distribution | |
| A5U-5570-C | In distribution | |
| A5U-4525R | In distribution | |
| A5R-55F-045 | In distribution | |
| A5R-60F-100 | In distribution | |
| A5P-5060R-C | In distribution | |
| A5R-55-040K | In distribution | |
| A5R-55FL-450 | In distribution | |
| A5M-6050R | In distribution | |
| A5P-4545-C | In distribution | |
| A5P-9560-C | In distribution | |
| A5X-F25 | In distribution | |
| A5P-6055 | In distribution | |
| A5R-60-600D | In distribution | |
| A5M-7050 | In distribution | |
| A5P-5070E-C | In distribution | |
| A5P-6570E-C | In distribution | |
| A5M-5050 | In distribution | |
| A5PSAI-9560-C | In distribution | |
| A5M-5550 | In distribution | |
| A5R-60FY-060K | In distribution | |
| A5P-7560-C | In distribution | |
| A5M-8545-C | In distribution | |
| A5R-55F-060K | In distribution | |
| A5P-6060E-C | In distribution | |
| A5H-B95 | In distribution | |
| A5P-6030 | In distribution | |
| A5P-8545 | In distribution | |
| A5M-7590R | In distribution | |
| A5P-7060-C | In distribution | |
| A5R-55C85-300K | In distribution | |
| A5R-60FY-050K | In distribution | |
| A5R-60F-085 | In distribution | |
| A5P-7525 | In distribution | |
| A5P-9570 | In distribution | |
| A5R-60F-075 | In distribution | |
| A5M-5030-C | In distribution | |
| A5R-60H-450D | In distribution | |
| A5M-9590R-C | In distribution | |
| A5M-4570R-C | In distribution | |
| A5M-7090 | In distribution | |
| A5M-5560-C | In distribution | |
| A5P-5030E-C | In distribution | |
| A5R-55L-120 | In distribution | |
| A5M-7545 | In distribution | |
| A5M-7055R | In distribution | |
| A5P-85100E-C | In distribution | |
| A5R-60-050 | In distribution | |
| A5M-4550-C | In distribution | |
| A5P-9525 | In distribution | |
| A5M-5030 | In distribution | |
| A5M-4540-C | In distribution | |
| A5P-8550R | In distribution | |
| A5R-55-325 | In distribution | |
| A5P-75100-C | In distribution | |
| A5U-7060R-C | In distribution | |
| A5P-9535R | In distribution | |
| A5RR-55R-150 | In distribution | |
| A5P-6580E-C | In distribution | |
| A5P-4550 | In distribution | |
| A5M-4570-C | In distribution | |
| A5R-60FL-300K | In distribution | |
| A5U-6045-C | In distribution | |
| A5U-6570 | In distribution |
Showing 250 of 300 catalogue numbers.
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.