GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES

Filler, Bone Void, Calcium Compound

OSTEOTECH INC

The following data is part of a premarket notification filed by Osteotech Inc with the FDA for Grafton R Ii Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium Salt Bone Void Filler Devices.

Pre-market Notification Details

Device IDK082615
510k NumberK082615
Device Name:GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES
ClassificationFiller, Bone Void, Calcium Compound
Applicant OSTEOTECH INC 51 JAMES WAY Eatontown,  NJ  07724
ContactChris Talbot
CorrespondentChris Talbot
OSTEOTECH INC 51 JAMES WAY Eatontown,  NJ  07724
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-09
Decision Date2008-10-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169141858 K082615 000
00613994986474 K082615 000
00613994986481 K082615 000
00613994986498 K082615 000
00613994986504 K082615 000
00613994986511 K082615 000
00613994986528 K082615 000
00613994986535 K082615 000
00613994986542 K082615 000
00613994986559 K082615 000
00643169103986 K082615 000
00643169103993 K082615 000
00643169104006 K082615 000
00643169104013 K082615 000
00613994986467 K082615 000

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