Cleared Traditional

Mineral Collagen Composite Bioactive Moldable

K182074 · Collagen Matrix, Inc. · Orthopedic
Mar 2019
Decision
232d
Days
Class 2
Risk

About This 510(k) Submission

K182074 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 March 21, 2019, 232 days after receiving the submission on August 1, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K182074 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2018
Decision Date March 21, 2019
Days to Decision 232 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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