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SP-FIX

GLOBUS MEDICAL, INC. · Model 388.522 · UDI-DI 00849044092240

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

Description

SP-Fix LP PEEK Barrel Assembly, 22mm

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.