INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP

Filler, Bone Void, Calcium Compound

INTEGRA LIFESCIENCE CORPORTATION

The following data is part of a premarket notification filed by Integra Lifescience Corportation with the FDA for Integra Mozaik Osteoconductive Scaffold - Strip.

Pre-market Notification Details

Device IDK141841
510k NumberK141841
Device Name:INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP
ClassificationFiller, Bone Void, Calcium Compound
Applicant INTEGRA LIFESCIENCE CORPORTATION 311 ENTERPRISE DRIVE Plainsboro,  NJ  08536
ContactNicole C Harlan
CorrespondentNicole C Harlan
INTEGRA LIFESCIENCE CORPORTATION 311 ENTERPRISE DRIVE Plainsboro,  NJ  08536
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-08
Decision Date2014-08-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M386560100501 K141841 000
M386CCM101551 K141841 000

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