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Benefix™ Interspinous Fixation System
CG MedTech Co.,Ltd. · Model IS20836L · UDI-DI 08800015919081
PEK
Prescription
10
510(k) clearances
61
Adverse events
1
Recalls
77
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-12-29 | XTANT Medical | The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert. |
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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.