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Velofix™ PEEK Lumbar Cage

CG MedTech Co.,Ltd. · Model PL0430 · UDI-DI 08800015954716

FZY Prescription
1
510(k) clearances
858
Adverse events
2
Recalls
266
Facilities

Recalls

DateFirmReason
2013-04-25SpineFrontier, Inc.Malfunction of slap hammer.
2008-05-07EBI, L.P.Customer complaint received regarding the separation of the mallet handle during a medical procedure.

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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.