PRO-DENSE LoVisc Bone Graft Substitute

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 Pro-dense Lovisc Bone Graft Substitute.

Pre-market Notification Details

Device IDK200507
510k NumberK200507
Device Name:PRO-DENSE LoVisc Bone Graft Substitute
ClassificationFiller, Bone Void, Calcium Compound
Applicant Wright Medical Technology, Inc. 1023 Cherry Road Memphis,  TN  38117
ContactRachel Roberts
CorrespondentRachel Roberts
Wright Medical Technology, Inc. 1023 Cherry Road Memphis,  TN  38117
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-02
Decision Date2020-10-21

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.