FDA Device Intelligence
Home › VY SPINE LLC › Interspinous Plate

Interspinous Plate

VY SPINE LLC · Model 12-45-L18 · UDI-DI 00842566101735

PEK Prescription
10
510(k) clearances
62
Adverse events
1
Recalls
78
Facilities

Description

Spinous Process Plate, 45x18, Large Plate, TI

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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.