Cleared Special

Mineral Collagen Composite Bioactive Extra Moldable

K231942 · Collagen Matrix, Inc. · Orthopedic
Aug 2023
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K231942 is an FDA 510(k) clearance for the Mineral Collagen Composite Bioactive Extra 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 August 2, 2023, 33 days after receiving the submission on June 30, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K231942 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2023
Decision Date August 02, 2023
Days to Decision 33 days
Submission Type Special
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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