SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX

Filler, Bone Void, Calcium Compound

COLLAGEN MATRIX, INC.

The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Synthetic Mineral-collagen Bone Graft Matrix.

Pre-market Notification Details

Device IDK092608
510k NumberK092608
Device Name:SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
ClassificationFiller, Bone Void, Calcium Compound
Applicant COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes,  NJ  07417
ContactPeggy Hansen
CorrespondentPeggy Hansen
COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes,  NJ  07417
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-25
Decision Date2010-05-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840420157096 K092608 000
00840420156983 K092608 000
00840420156990 K092608 000
00840420157003 K092608 000
00840420157010 K092608 000
00840420157027 K092608 000
00840420157034 K092608 000
00840420157041 K092608 000
00840420157058 K092608 000
00840420156976 K092608 000

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