MCP Bone Putty

Filler, Bone Void, Calcium Compound

BioStructures, LLC

The following data is part of a premarket notification filed by Biostructures, Llc with the FDA for Mcp Bone Putty.

Pre-market Notification Details

Device IDK160446
510k NumberK160446
Device Name:MCP Bone Putty
ClassificationFiller, Bone Void, Calcium Compound
Applicant BioStructures, LLC 1201 Dove Street, Suite 470 Newport Beach,  CA  92660
ContactJohn Brunelle
CorrespondentPatty J. Trisler
Trisler Consulting 5600 Wisconsin Ave Chevy Chase,  MD  20815
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-17
Decision Date2016-11-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816986020129 K160446 000
00816986020112 K160446 000

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