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510(k) K252686

EffortMed PEEK Cages & Corpectomy Cages by Effortmed, LLC — Product Code ODP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2025
Date Received
August 26, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Effortmed, LLC

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  • K240935 — ARENAL Anterior Cervical Plate System (May 17, 2024)

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