Cleared Traditional

Mineral Collagen Composite Bioactive Moldable

K221735 · Collagen Matrix, Inc. · Orthopedic
Dec 2022
Decision
188d
Days
Class 2
Risk

About This 510(k) Submission

K221735 is an FDA 510(k) clearance for the Mineral Collagen Composite Bioactive Moldable, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Collagen Matrix, Inc. (Oakland, US). The FDA issued a Cleared decision on December 20, 2022, 188 days after receiving the submission on June 15, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K221735 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2022
Decision Date December 20, 2022
Days to Decision 188 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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