Cleared Traditional

Tactoset

K223915 · Anika Therapeutics, Inc. · Orthopedic
Mar 2023
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K223915 is an FDA 510(k) clearance for the Tactoset, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Anika Therapeutics, Inc. (Beford, US). The FDA issued a Cleared decision on March 29, 2023, 90 days after receiving the submission on December 29, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K223915 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2022
Decision Date March 29, 2023
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQV — Filler, Bone Void, Calcium Compound
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3045

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