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Left Alignment Gauge Superior Crossbars Long

PREMIA SPINE LTD · Model 83107 · UDI-DI 07290115932829

QWK Prescription
0
510(k) clearances
49
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.