Cleared Traditional

K062200 - COLLAGEN MATRIX ANORGANIC BONE MINERAL ...

K062200 is the FDA 510(k) clearance for COLLAGEN MATRIX ANORGANIC BONE MINERAL ... by Collagen Matrix, Inc.. It is a Class 2 Orthopedic device (product code MQV) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K062200 · Collagen Matrix, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 2007
Decision
196d
Days
Class 2
Risk

K062200 is an FDA 510(k) clearance for the COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Collagen Matrix, Inc. (Franklin Lakes, US). The FDA issued a Cleared decision on February 13, 2007 after a review of 196 days - an extended review cycle.

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 Collagen Matrix, Inc. devices

Submission Details

510(k) Number K062200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2006
Decision Date February 13, 2007
Days to Decision 196 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
74d slower than avg
Panel avg: 122d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 232
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K062200.
PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT
K072597 · Wrightmedicaltechnologyinc · Oct 2007
PRO-DENSE BONE VOID FILLER
K070437 · Wrightmedicaltechnologyinc · May 2007
PRO OSTEON 500R
K063346 · Ebi, L.P. · Apr 2007
OSFERION
K061499 · Olympus America, Inc. · Jan 2007
MOZAIK BONE REGENERATION MATRIX - PUTTY
K062353 · Integra LifeSciences Corporation · Dec 2006
HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM
K062495 · Depuy Spine, Inc. · Oct 2006