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CirFIX® Cranial bone fixation system: Flap Fixator (3 PCS)
OSSAWARE BIOTECH CO., LTD. · Model 9903.0101.15S · UDI-DI 04717002404175
GXR
Prescription
1
510(k) clearances
210
Adverse events
1
Recalls
52
Facilities
Description
CUSMED Flap Fixator, Low Profile Replaceable Type+Screwdriver, PEEK, D15mm, Sterile (3 PCS)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-06-02 | Medtronic Neuromodulation | Excess nylon flash on the clip. |
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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.