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ARx SAI

Life Spine, Inc. · Model 17-12585-09 · UDI-DI 00190837196523

OURNKB Prescription
1
510(k) clearances
1,406
Adverse events (5 deaths)
1
Recalls
154
Facilities

Recalls

DateFirmReason
2025-11-03Orthofix U.S. LLCLabeling contains claims that are not consistently present.

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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.