Coral
Hex-End Straight Rod 5.5 x 500. The Coral Spinal System consists of a variety of types and sizes of rods, hooks, screws, and connectors. The Coral Spinal System implant components can be…
Hex-End Straight Rod 5.5 x 500. The Coral Spinal System consists of a variety of types and sizes of rods, hooks, screws, and connectors. The Coral Spinal System implant components can be rigidly locked into a variety of configurations that can be fit for the individual case. The Coral Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136, ASTM-F-67, and cobalt chrome alloy per ASTM F-1537.
11manufacturers in China registered for this device type
216catalogue numbers in this listing
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 | Seaspine Orthopedics Corporation, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K041592 |
| Record published | 2015-09-24 |
| Record revised | 2025-10-24 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2016-09-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 18-22-6560 | 6.50mm x 60mm | In distribution |
| 18-24-9540 | 9.50mm x 40mm | In distribution |
| 18-12-4520 | 4.75mm x 20mm | In distribution |
| 18-14-4585 | 4.75mm x 85mm | In distribution |
| 18-24-6535 | 6.50mm x 35mm | In distribution |
| 18-12-7545 | 7.50mm x 45mm | In distribution |
| 10-10-8530 | 8.50mm x 30mm | In distribution |
| 18-16-9595 | 9.50mm x 95mm | In distribution |
| 18-14-6535 | 6.50mm x 35mm | In distribution |
| 18-24-9575 | 9.50mm x 75mm | In distribution |
| 18-16-7530 | 7.50mm x 30mm | In distribution |
| 10-18-0090 | 5.5mm x 90mm | In distribution |
| 18-12-6535 | 6.50mm x 35mm | In distribution |
| 18-14-7520 | 7.50mm x 20mm | In distribution |
| 18-22-9560 | 9.50mm x 60mm | In distribution |
| 18-14-4520 | 4.75mm x 20mm | In distribution |
| 18-12-8525 | 8.50mm x 25mm | In distribution |
| 18-24-4565 | 4.75mm x 65mm | In distribution |
| 10-22-0224 | 24mm | In distribution |
| 18-24-9545 | 9.50mm x 45mm | In distribution |
| 18-26-4525 | 4.75mm x 25mm | In distribution |
| 18-22-7540 | 7.50mm x 40mm | In distribution |
| 10-21-1604-L | In distribution | |
| 18-24-8545 | 8.50mm x 45mm | In distribution |
| 18-12-5550 | 5.50mm x 50mm | In distribution |
| 18-14-5555 | 5.50mm x 55mm | In distribution |
| 18-16-9590 | 9.50mm x 90mm | In distribution |
| 18-16-8530 | 8.50mm x 30mm | In distribution |
| 10-10-6520 | 6.50mm x 20mm | In distribution |
| 18-14-9560 | 9.50mm x 60mm | In distribution |
| 10-10-4560 | 4.75mm x 60mm | In distribution |
| 10-10-7530 | 7.50mm x 30mm | In distribution |
| 18-16-4540 | 4.75mm x 40mm | In distribution |
| 18-22-9525 | 9.50mm x 25mm | In distribution |
| 18-12-5575 | 5.50mm x 75mm | In distribution |
| 18-26-9525 | 9.50mm x 25mm | In distribution |
| 10-12-6535 | 6.50mm x 35mm | In distribution |
| 18-16-8545 | 8.50mm x 45mm | In distribution |
| 18-26-9550 | 9.50mm x 50mm | In distribution |
| 18-16-9550 | 9.50mm x 50mm | In distribution |
| 18-22-8555 | 8.50mm x 55mm | In distribution |
| 10-12-6560 | 6.50mm x 60mm | In distribution |
| 10-25-0600 | 5.5 x 600 | In distribution |
| 18-12-4585 | 4.75mm x 85mm | In distribution |
| 18-14-4530 | 4.75mm x 30mm | In distribution |
| 18-14-7530 | 7.50mm x 30mm | In distribution |
| 18-14-9565 | 9.50mm x 65mm | In distribution |
| 18-26-7525 | 7.50mm x 25mm | In distribution |
| 10-22-0238 | 38mm X-Conn | In distribution |
| 10-12-4530 | 4.75mm x 30mm | In distribution |
| TRANSIMP | In distribution | |
| 18-26-8520 | 8.50mm x 20mm | In distribution |
| 18-12-8550 | 8.50mm x 50mm | In distribution |
| 18-14-7595 | 7.50mm x 95mm | In distribution |
| 18-14-4590 | 4.75mm x 90mm | In distribution |
| 10-12-7555 | 7.50mm x 55mm | In distribution |
| 18-12-6565 | 6.50mm x 65mm | In distribution |
| 18-24-7550 | 7.50mm x 50mm | In distribution |
| 10-10-9530 | 9.50mm x 30mm | In distribution |
| 18-22-5535 | 5.50mm x 35mm | In distribution |
| 10-10-8590 | 8.50mm x 90mm | In distribution |
| 18-22-9575 | 9.50mm x 75mm | In distribution |
| 10-24-1120 | 20mm | In distribution |
| 18-22-6540 | 6.50mm x 40mm | In distribution |
| 10-12-7540 | 7.50mm x 40mm | In distribution |
| 18-16-8565 | 8.50mm x 65mm | In distribution |
| 18-24-7560 | 7.50mm x 60mm | In distribution |
| 18-24-9560 | 9.50mm x 60mm | In distribution |
| 10-21-1804-L | In distribution | |
| 18-22-8545 | 8.50mm x 45mm | In distribution |
| 18-16-9565 | 9.50mm x 65mm | In distribution |
| 10-25-0500 | 5.5mm x 500mm Rod | In distribution |
| 18-26-4530 | 4.75mm x 30mm | In distribution |
| 10-12-7530 | 7.50mm x 30mm | In distribution |
| 10-18-0160 | 5.5mm x 160mm | In distribution |
| 10-10-8595 | 8.50mm x 95mm | In distribution |
| 18-12-5565 | 5.50mm x 65mm | In distribution |
| 18-16-6535 | 6.50mm x 35mm | In distribution |
| 18-24-5550 | 5.50mm x 50mm | In distribution |
| 18-22-6525 | 6.50mm x 25mm | In distribution |
| 18-24-7540 | 7.50mm x 40mm | In distribution |
| 18-14-8585 | 8.50mm x 85mm | In distribution |
| 18-22-7520 | 7.50mm x 20mm | In distribution |
| 10-10-8585 | 8.50mm x 85mm | In distribution |
| 18-16-4555 | 4.75mm x 55mm | In distribution |
| 10-24-1125 | 25mm | In distribution |
| 10-12-7560 | 7.50mm x 60mm | In distribution |
| 10-10-8570 | 8.50mm x 70mm | In distribution |
| 18-12-9575 | 9.50mm x 75mm | In distribution |
| 18-16-9540 | 9.50mm x 40mm | In distribution |
| 10-10-6590 | 6.50mm x 90mm | In distribution |
| 18-24-4525 | 4.75mm x 25mm | In distribution |
| 18-16-5580 | 5.50mm x 80mm | In distribution |
| 18-24-4550 | 4.75mm x 50mm | In distribution |
| 18-22-8530 | 8.50mm x 30mm | In distribution |
| 18-14-8520 | 8.50mm x 20mm | In distribution |
| 10-12-5550 | 5.50mm x 50mm | In distribution |
| 18-16-7575 | 7.50mm x 75mm | In distribution |
| 18-24-7520 | 7.50mm x 20mm | In distribution |
| 18-19-0025 | 5.5 x 25 | In distribution |
| 10-12-5545 | 5.50mm x 45mm | In distribution |
| 18-26-7530 | 7.50mm x 30mm | In distribution |
| 10-18-0450 | 5.5mm x 450mm Rod | In distribution |
| 18-22-8590 | 8.50mm x 90mm | In distribution |
| 18-14-9550 | 9.50mm x 50mm | In distribution |
| 18-26-9545 | 9.50mm x 45mm | In distribution |
| 18-14-6580 | 6.50mm x 80mm | In distribution |
| 18-24-9595 | 9.50mm x 95mm | In distribution |
| 18-12-9590 | 9.50mm x 90mm | In distribution |
| 18-16-4535 | 4.75mm x 35mm | In distribution |
| 10-10-4035 | 4.00mm x 35mm | In distribution |
| 18-14-9575 | 9.50mm x 75mm | In distribution |
| 18-14-4525 | 4.75mm x 25mm | In distribution |
| 10-12-6545 | 6.50mm x 45mm | In distribution |
| 18-24-4530 | 4.75mm x 30mm | In distribution |
| 18-26-7585 | 7.50mm x 85mm | In distribution |
| 10-19-0035 | 5.5mm x 35mm | In distribution |
| 18-22-7550 | 7.50mm x 50mm | In distribution |
| 18-24-8530 | 8.50mm x 30mm | In distribution |
| 10-18-0200 | 5.5mm x 200mm Rod | In distribution |
| 18-12-9530 | 9.50mm x 30mm | In distribution |
| 18-26-9590 | 9.50mm x 90mm | In distribution |
| 18-24-9590 | 9.50mm x 90mm | In distribution |
| 18-12-9555 | 9.50mm x 55mm | In distribution |
| 18-22-7595 | 7.50mm x 95mm | In distribution |
| 18-16-4560 | 4.75mm x 60mm | In distribution |
| 18-14-7555 | 7.50mm x 55mm | In distribution |
| 18-12-7585 | 7.50mm x 85mm | In distribution |
| 18-22-4040 | 4.00mm x 40mm | In distribution |
| 18-12-4540 | 4.75mm x 40mm | In distribution |
| 18-12-5520 | 5.50mm x 20mm | In distribution |
| 18-16-5525 | 5.50mm x 25mm | In distribution |
| 18-16-4595 | 4.75mm x 95mm | In distribution |
| 10-10-6560 | 6.50mm x 60mm | In distribution |
| 18-26-8565 | 8.50mm x 65mm | In distribution |
| 10-10-4025 | 4.00mm x 25mm | In distribution |
| 18-12-7595 | 7.50mm x 95mm | In distribution |
| 10-19-0060 | 5.5mm x 60mm | In distribution |
| 10-19-0070 | 5.5mm x 70mm | In distribution |
| 10-21-0409 | In distribution | |
| 10-12-4040 | 4.00mm x 40mm | In distribution |
| 18-12-8540 | 8.50mm x 40mm | In distribution |
| 18-24-9555 | 9.50mm x 55mm | In distribution |
| 18-16-7580 | 7.50mm x 80mm | In distribution |
| 10-10-4530 | 4.75mm x 30mm | In distribution |
| 18-14-4545 | 4.75mm x 45mm | In distribution |
| 18-24-4545 | 4.75mm x 45mm | In distribution |
| 10-10-4060 | 4.00mm x 60mm | In distribution |
| 18-14-5580 | 5.50mm x 80mm | In distribution |
| 18-12-6540 | 6.50mm x 40mm | In distribution |
| 18-16-9525 | 9.50mm x 25mm | In distribution |
| 18-16-4530 | 4.75mm x 30mm | In distribution |
| 10-22-0101 | In distribution | |
| 18-16-5535 | 5.50mm x 35mm | In distribution |
| 18-12-4095 | 4.00mm x 95mm | In distribution |
| 18-12-4040 | 4.00mm x 40mm | In distribution |
| 18-16-9520 | 9.50mm x 20mm | In distribution |
| 18-22-8565 | 8.50mm x 65mm | In distribution |
| 18-16-9585 | 9.50mm x 85mm | In distribution |
| 18-14-5530 | 5.50mm x 30mm | In distribution |
| 18-12-9565 | 9.50mm x 65mm | In distribution |
| 18-16-5585 | 5.50mm x 85mm | In distribution |
| 18-12-8530 | 8.50mm x 30mm | In distribution |
| 10-12-7575 | 7.50mm x 75mm | In distribution |
| 18-24-9550 | 9.50mm x 50mm | In distribution |
| 18-12-4545 | 4.75mm x 45mm | In distribution |
| 18-24-9520 | 9.50mm x 20mm | In distribution |
| 10-10-4535 | 4.75mm x 35mm | In distribution |
| 10-22-0214 | 14mm | In distribution |
| 18-16-4590 | 4.75mm x 90mm | In distribution |
| 18-22-8580 | 8.50mm x 80mm | In distribution |
| 18-16-6520 | 6.50mm x 20mm | In distribution |
| 10-10-7550 | 7.50mm x 50mm | In distribution |
| 18-24-6545 | 6.50mm x 45mm | In distribution |
| 10-21-0204 | In distribution | |
| 18-22-5530 | 5.50mm x 30mm | In distribution |
| 18-24-4560 | 4.75mm x 60mm | In distribution |
| 18-16-4575 | 4.75mm x 75mm | In distribution |
| 10-10-4055 | 4.00mm x 55mm | In distribution |
| 18-12-5580 | 5.50mm x 80mm | In distribution |
| 18-14-6525 | 6.50mm x 25mm | In distribution |
| 10-10-9580 | 9.50mm x 80mm | In distribution |
| 18-26-7535 | 7.50mm x 35mm | In distribution |
| 10-10-4045 | 4.00mm x 45mm | In distribution |
| 10-12-5535 | 5.50mm x 35mm | In distribution |
| 18-14-8570 | 8.50mm x 70mm | In distribution |
| 18-12-5555 | 5.50mm x 55mm | In distribution |
| 18-16-9560 | 9.50mm x 60mm | In distribution |
| 10-11-6565 | 6.50mm x 65mm | Withdrawn |
| 10-11-8565 | 8.50mm x 65mm | Withdrawn |
| 10-11-8545 | 8.50mm x 45mm | Withdrawn |
| 10-11-5565 | 5.50mm x 65mm | Withdrawn |
| 10-11-8570 | 8.50mm x 70mm | Withdrawn |
| 10-11-8560 | 8.50mm x 60mm | Withdrawn |
| 10-11-9560 | 9.50mm x 60mm | Withdrawn |
| 10-11-7555 | 7.50mm x 55mm | Withdrawn |
| 10-11-4555 | 4.75mm x 55mm | Withdrawn |
| 10-11-4535 | 4.75mm x 35mm | Withdrawn |
| 10-11-7540 | 7.50mm x 40mm | Withdrawn |
| 10-11-8575 | 8.50mm x 75mm | Withdrawn |
| 10-11-9570 | 9.50mm x 70mm | Withdrawn |
| 10-11-9585 | 9.50mm x 85mm | Withdrawn |
| 10-12-6590 | 6.50mm x 90mm | Withdrawn |
| 10-11-9575 | 9.50mm x 75mm | Withdrawn |
| 10-11-5540 | 5.50mm x 40mm | Withdrawn |
| 10-11-7530 | 7.50mm x 30mm | Withdrawn |
| 10-12-6580 | 6.50mm x 80mm | Withdrawn |
| 10-11-7545 | 7.50mm x 45mm | Withdrawn |
| 10-11-4525 | 4.75mm x 25mm | Withdrawn |
| 10-11-4050 | 4.00mm x 50mm | Withdrawn |
| 10-11-5525 | 5.50mm x 25mm | Withdrawn |
| 10-11-4545 | 4.75mm x 45mm | Withdrawn |
| 10-12-4050 | 4.00mm x 50mm | Withdrawn |
| 10-11-5550 | 5.50mm x 50mm | Withdrawn |
| 10-11-9550 | 9.50mm x 50mm | Withdrawn |
| 10-11-9530 | 9.50mm x 30mm | Withdrawn |
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
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.