VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE

Filler, Bone Void, Calcium Compound

ORTHOVITA, INC.

The following data is part of a premarket notification filed by Orthovita, Inc. with the FDA for Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive Foam Bone Graft Substitute.

Pre-market Notification Details

Device IDK083033
510k NumberK083033
Device Name:VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE
ClassificationFiller, Bone Void, Calcium Compound
Applicant ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern,  PA  19355
ContactDeborah L Jackson
CorrespondentDeborah L Jackson
ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern,  PA  19355
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-10
Decision Date2008-11-06
Summary:summary

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