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510(k) K250997

Integrity Implant by Anika Therapeutics, Inc. — Product Code OWX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 17, 2025
Date Received: April 1, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
Device Class: Class II
Regulation Number: 878.3300
Review Panel: OR
Submission Type

For reinforcement of soft tissue where weakness exists in tendon repair.

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K223538 — Integrity Implant (August 17, 2023)
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K222487 — Anika Tissue Tack Fixation System (May 8, 2023)
K223915 — Tactoset (March 29, 2023)
K212083 — Tactoset Injectable Bone Substitute (August 31, 2021)
K190956 — SCS 17-01 (January 30, 2020)
K173008 — SCS 17-01 (December 26, 2017)