NovaBone IRM

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 Irm.

Pre-market Notification Details

Device IDK163310
510k NumberK163310
Device Name:NovaBone IRM
ClassificationFiller, Bone Void, Calcium Compound
Applicant NovaBone Products, LLC 13510 NW US Highway 441 Alachua,  FL  32615
ContactGregory Pomrink
CorrespondentLisa C. Simpson
Simpson Regulatory Solutions, LLC 4401 NW 18th Place Gainesville,  FL  32605
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-23
Decision Date2017-01-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00813909011769 K163310 000
00813909012896 K163310 000
00813909012902 K163310 000
00813909011639 K163310 000
00813909011646 K163310 000
00813909011653 K163310 000
00813909011660 K163310 000
00813909011677 K163310 000
00813909011691 K163310 000
00813909011707 K163310 000
00813909011714 K163310 000
00813909011721 K163310 000
00813909011738 K163310 000
00813909011745 K163310 000
00813909012889 K163310 000

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