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Coral
Seaspine Orthopedics Corporation · Model 18-30-0050 · UDI-DI 10889981028060
1
510(k) clearances
10,584
Adverse events (59 deaths)
214
Recalls
360
Facilities
Description
Prebent Hex Rod 5.5 x 50mm. 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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-20 | Clariance-SAS | Due to a quality issue regarding the presence of burr on the finished cervical plate product. |
| 2021-04-26 | Alphatec Spine, Inc. | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| 2021-04-26 | Alphatec Spine, Inc. | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| 2021-04-26 | Alphatec Spine, Inc. | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| 2021-04-26 | Alphatec Spine, Inc. | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| 2021-04-26 | Alphatec Spine, Inc. | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| 2021-04-26 | Alphatec Spine, Inc. | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| 2021-04-26 | Alphatec Spine, Inc. | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| 2021-04-26 | Alphatec Spine, Inc. | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| 2021-04-26 | Alphatec Spine, Inc. | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.