Cleared Traditional

PRO-DENSE LoVisc Bone Graft Substitute

K200507 · Wrightmedicaltechnologyinc · Orthopedic
Oct 2020
Decision
233d
Days
Class 2
Risk

About This 510(k) Submission

K200507 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 October 21, 2020, 233 days after receiving the submission on March 2, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K200507 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2020
Decision Date October 21, 2020
Days to Decision 233 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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