OSTEOSET BVF KIT

Filler, Bone Void, Calcium Compound

WRIGHT MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Osteoset Bvf Kit.

Pre-market Notification Details

Device IDK010532
510k NumberK010532
Device Name:OSTEOSET BVF KIT
ClassificationFiller, Bone Void, Calcium Compound
Applicant WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
ContactEhab M Esmail
CorrespondentEhab M Esmail
WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-02-23
Decision Date2001-10-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840420133724 K010532 000
00840420133663 K010532 000

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