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Spinous Process System

Seaspine Orthopedics Corporation · Model 95-3108 · UDI-DI 10889981096243

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

Description

8mm Trial, Spinous Process Spacer

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.