Cleared Traditional

Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix

K240424 · Collagen Matrix, Inc. · Orthopedic
Mar 2024
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K240424 is an FDA 510(k) clearance for the Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix, 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 March 12, 2024, 28 days after receiving the submission on February 13, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K240424 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2024
Decision Date March 12, 2024
Days to Decision 28 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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