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ROMEO 2 PAD POSTERIOR AXIAL DEVICE

SpineArt SA · Model PAD-IM TI 12-S · UDI-DI 07640151087609

PEK Prescription
10
510(k) clearances
61
Adverse events
1
Recalls
77
Facilities

Description

Posterior Axial Device - Titanium

Recalls

DateFirmReason
2021-12-29XTANT MedicalThe proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.

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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.