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Optima™ Spinal System
CG MedTech Co.,Ltd. · Model SP0011 · UDI-DI 08800015951999
HXO
Prescription
3
510(k) clearances
58
Adverse events
1
Recalls
75
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-08-02 | Biomet, Inc. | The firm has received four complaints that the closed knot pusher is missing a radius which contributes to sutures being cut during surgery. |
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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.