Cleared Traditional

INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS

K063124 · Integra Lifesciences Corp. · Orthopedic
Jan 2007
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K063124 is an FDA 510(k) clearance for the INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Integra Lifesciences Corp. (Plainsboro, US). The FDA issued a Cleared decision on January 19, 2007, 98 days after receiving the submission on October 13, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K063124 FDA.gov
FDA Decision Cleared SESE
Date Received October 13, 2006
Decision Date January 19, 2007
Days to Decision 98 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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