NOVABONE PUTTY - RESORBABLE BONE VOID FILLER

Filler, Bone Void, Calcium Compound

NovaBone Products, LLC

The following data is part of a premarket notification filed by Novabone Products, Llc with the FDA for Novabone Putty - Resorbable Bone Void Filler.

Pre-market Notification Details

Device IDK051617
510k NumberK051617
Device Name:NOVABONE PUTTY - RESORBABLE BONE VOID FILLER
ClassificationFiller, Bone Void, Calcium Compound
Applicant NovaBone Products, LLC 13709 PROGRESS BLVD., #33 Alachua,  FL  32615
ContactDavid M Gaisser
CorrespondentDavid M Gaisser
NovaBone Products, LLC 13709 PROGRESS BLVD., #33 Alachua,  FL  32615
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-17
Decision Date2006-03-06
Summary:summary

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