Cleared Traditional

K062200 - COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS

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

K062200 · Collagen Matrix, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K062200

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.

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 401
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K062200.
COPIOS BONE VOID FILLER SPONGE AND PASTE
K071237 · Kensey Nash Corp. · Jun 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
INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS
K063124 · Integra Lifesciences Corp. · Jan 2007
DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX
K053218 · Musculoskeletal Transplant Foundation · Dec 2006