Cleared Traditional

Tactoset? Injectable Bone Substitute

K231968 · Anika Therapeutics, Inc. · Orthopedic
Dec 2023
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K231968 is an FDA 510(k) clearance for the Tactoset? Injectable Bone Substitute, 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 December 20, 2023, 170 days after receiving the submission on July 3, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K231968 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2023
Decision Date December 20, 2023
Days to Decision 170 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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