Cleared Traditional

PRO-DENSE LoVisc Bone Graft Substitute

K213342 · Wrightmedicaltechnologyinc · Orthopedic
Jan 2022
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K213342 is an FDA 510(k) clearance for the PRO-DENSE LoVisc Bone Graft Substitute, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on January 5, 2022, 90 days after receiving the submission on October 7, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K213342 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 2021
Decision Date January 05, 2022
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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