Cleared Traditional

Anika Tissue Tack Fixation System

K222487 · Anika Therapeutics, Inc. · General & Plastic Surgery
May 2023
Decision
264d
Days
Class 2
Risk

About This 510(k) Submission

K222487 is an FDA 510(k) clearance for the Anika Tissue Tack Fixation System, a Staple, Implantable (Class II — Special Controls, product code GDW), submitted by Anika Therapeutics, Inc. (Beford, US). The FDA issued a Cleared decision on May 8, 2023, 264 days after receiving the submission on August 17, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.

Submission Details

510(k) Number K222487 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 2022
Decision Date May 08, 2023
Days to Decision 264 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GDW — Staple, Implantable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4750

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