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OPTIMA™ Spinal System
CG MedTech Co.,Ltd. · Model SP0018 · UDI-DI 08800037575142
HXP
Prescription
5
510(k) clearances
156
Adverse events
1
Recalls
158
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-06-22 | Synthes USA HQ, Inc. | A complaint was received of the tips of the Matrix 5.5.mm Left and Right Coronal Bender breaking while bending a spinal rod component of the Matrix System. |
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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.