NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT

Filler, Bone Void, Calcium Compound

PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, I

The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc. (rti Surgical, I with the FDA for Nanoss Bioactive, Nanoss Bioactive Loaded, And Nanoss Bioactive Loaded Kit.

Pre-market Notification Details

Device IDK141600
510k NumberK141600
Device Name:NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT
ClassificationFiller, Bone Void, Calcium Compound
Applicant PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, I 375 RIVER PARK CIRCLE Marquette,  MI  49855
ContactSarah Mcintyre
CorrespondentSarah Mcintyre
PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, I 375 RIVER PARK CIRCLE Marquette,  MI  49855
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2014-06-16
Decision Date2014-10-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00849777012454 K141600 000
00849777012447 K141600 000
00849777012430 K141600 000
00849777012423 K141600 000
00849777012416 K141600 000
00849777012409 K141600 000
00849777012393 K141600 000

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