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Spinous Process Plate
FDA product code PEK · Class 2 · Orthopedic
1,313
Registered devices
61
Adverse events
1
Recalls
48
510(k) clearances
Devices with this code
Huvex — DIOMEDICAL CO.,LTD.Interspinous Plate System — PRECISION SPINE, INC.Axle Interspinous Fusion System — Xtant Medical Holdings, Inc.Axle Interspinous Fusion System — Xtant Medical Holdings, Inc.Aileron — Life Spine, Inc.Interspinous Plate System — PRECISION SPINE, INC.InterBRIDGE — LDR Spine Usa, Inc.Axle Interspinous Fusion System — Xtant Medical Holdings, Inc.Axle Interspinous Fusion System — Xtant Medical Holdings, Inc.SP-FIX — GLOBUS MEDICAL, INC.Benefix™ Interspinous Fixation System — CG MedTech Co.,Ltd.ZIP — AURORA SPINE, INC.Aileron Posterior Fusion System — Life Spine, Inc.SP-FIX — GLOBUS MEDICAL, INC.Benefix™ Interspinous Fixation System — CG MedTech Co.,Ltd.Axle Interspinous Fusion System — Xtant Medical Holdings, Inc.Axle Interspinous Fusion System — Xtant Medical Holdings, Inc.Aileron Posterior Fusion System — Life Spine, Inc.Benefix™ Interspinous Fixation System — CG MedTech Co.,Ltd.Benefix™ Interspinous Fixation System — CG MedTech Co.,Ltd.Aileron Expandable Posterior Fusion System — Life Spine, Inc.Aileron Posterior Fusion System — Life Spine, Inc.VIA Spinous Process Fixation System — SPINEOLOGY INC.Benefix™ 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 |
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