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 IDK213342
510k NumberK213342
Device Name:PRO-DENSE LoVisc Bone Graft Substitute
ClassificationFiller, Bone Void, Calcium Compound
Applicant Wright Medical Technology, Inc. 1023 Cherry Road Memphis,  TN  38117
ContactLeslie Fitch
CorrespondentLeslie Fitch
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 Received2021-10-07
Decision Date2022-01-05

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