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Affix

Nuvasive, Inc. · Model 7579040 · UDI-DI 00887517063687

PEKKWP Prescription
5
510(k) clearances
62
Adverse events
1
Recalls
78
Facilities

Description

Affix II S Bladed Plate, 40mm

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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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.