Home › Device types › PEK
Spinous Process Plate
FDA product code PEK · Class 2 · Orthopedic
1,313
Registered devices
62
Adverse events
1
Recalls
49
510(k) clearances
Devices with this code
Kalitec Direct InSePtion MIS Fixation System — Kalitec Direct LLCBenefix™ Interspinous Fixation System — CG MedTech Co.,Ltd.Aileron Posterior Fusion System — Life Spine, Inc.Axle Interspinous Fusion System — Xtant Medical Holdings, Inc.Axle Interspinous Fusion System — Xtant Medical Holdings, Inc.Axle Interspinous Fusion System — Xtant Medical Holdings, Inc.Benefix™ Interspinous Fixation System — CG MedTech Co.,Ltd.KeyLift™ — FLOSPINE LLCAileron — Life Spine, Inc.VIA Spinous Process Fixation System — SPINEOLOGY INC.Aileron Posterior Fusion System — Life Spine, Inc.Aileron Posterior Fusion System — Life Spine, Inc.Benefix™ Interspinous Fixation System — CG MedTech Co.,Ltd.Axle Interspinous Fusion System — Xtant Medical Holdings, Inc.Interspinous Plate System — PRECISION SPINE, INC.AERIAL — GLOBUS MEDICAL, INC.Benefix™ Interspinous Fixation System — CG MedTech Co.,Ltd.Benefix™ Interspinous Fixation System — CG MedTech Co.,Ltd.InterBRIDGE — LDR Spine Usa, Inc.Benefix™ Interspinous Fixation System — CG MedTech Co.,Ltd.Aileron Posterior Fusion System — Life Spine, Inc.Benefix™ Interspinous Fixation System — CG MedTech Co.,Ltd.Spinous Process System — Seaspine Orthopedics CorporationBenefix™ Interspinous Fixation System — CG MedTech Co.,Ltd.
Recent 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 inser |
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 docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.