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SST 316 LVM, Blunt-Sharp Tip, Blunt- Sharp Tip, L=470, Ø1.5 over the K-Wire

PREMIA SPINE LTD · Model 86264 · UDI-DI 07290014381209

QWK Prescription
4
510(k) clearances
51
Adverse events
1
Recalls
6
Facilities

Recalls

DateFirmReason
2025-07-16PREMIA SPINE LTDPotential for missing pins at tip of inserter.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.