Cleared Traditional

K063124 - INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS

K063124 is an FDA 510(k) clearance for INTEGRA MOZAIK BONE REGENERATION MATRIX..., manufactured by Integra Lifesciences Corp.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 98-day FDA review.

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

K063124 is an FDA 510(k) clearance for the INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Integra Lifesciences Corp. (Plainsboro, US). The FDA issued a Cleared decision on January 19, 2007 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Integra Lifesciences Corp. devices

FDA 510(k) Submission Details - K063124

510(k) Number K063124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQV Device Classification - Class 2, Special Controls

Product Code MQV Filler, Bone Void, Calcium Compound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MQV Filler, Bone Void, Calcium Compound

All 392
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K063124.
PRO OSTEON 500R
K063346 · Ebi, L.P. · Apr 2007
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K062200 · Collagen Matrix, Inc. · Feb 2007
OSFERION
K061499 · Olympus America, Inc. · Jan 2007
DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX
K053218 · Musculoskeletal Transplant Foundation · Dec 2006
MOZAIK BONE REGENERATION MATRIX - PUTTY
K062353 · Integra LifeSciences Corporation · Dec 2006
BF+ (PH)
K061462 · Ldr Spine USA · Dec 2006