NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD

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 Porous - Synthetic Bone Graft Scaffold.

Pre-market Notification Details

Device IDK090731
510k NumberK090731
Device Name:NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-03-19
Decision Date2009-04-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00813909011226 K090731 000
00813909012926 K090731 000
00813909010908 K090731 000
00813909010915 K090731 000
00813909010922 K090731 000
00813909010946 K090731 000
00813909010953 K090731 000
00813909010960 K090731 000
00813909011141 K090731 000
00813909011158 K090731 000
00813909011219 K090731 000
00813909012919 K090731 000

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