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CirFIX® Cranial bone fixation system: Burr Hole Cover

OSSAWARE BIOTECH CO., LTD. · Model 9906.0014.11S · UDI-DI 04717002404335

GXR Prescription
1
510(k) clearances
210
Adverse events
1
Recalls
52
Facilities

Description

CUSMED CirFIX® Burr Hole Cover, Radiolucent Revisable Type for Shunt & ICP+Screwdriver, PEEK, 14mm/11mm, Sterile

Recalls

DateFirmReason
2021-06-02Medtronic NeuromodulationExcess nylon flash on the clip.

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Data 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.