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Interspinous Plate System
PRECISION SPINE, INC. · Model 29-LF-4020 · UDI-DI 00815362022641
PEK
Prescription
1
510(k) clearances
61
Adverse events
1
Recalls
77
Facilities
Description
Self Drilling Ø4.0mm Fixed Screw 20mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-12-29 | XTANT Medical | The 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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Get your free API keyRead the docsData 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.