Cleared Traditional

Genex Bone Graft Substitute

K212721 · Biocomposites, Ltd. · Orthopedic
Feb 2022
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K212721 is an FDA 510(k) clearance for the Genex Bone Graft Substitute, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Biocomposites, Ltd. (Keele, GB). The FDA issued a Cleared decision on February 4, 2022, 161 days after receiving the submission on August 27, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K212721 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 2021
Decision Date February 04, 2022
Days to Decision 161 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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