INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP

Instrument, Ultrasonic Surgical

INTEGRA BURLINGTON MA, INC.

The following data is part of a premarket notification filed by Integra Burlington Ma, Inc. with the FDA for Integra Cusa Nxt Inferior Foward Bone Tip.

Pre-market Notification Details

Device IDK113570
510k NumberK113570
Device Name:INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP
ClassificationInstrument, Ultrasonic Surgical
Applicant INTEGRA BURLINGTON MA, INC. 22 TERRY AVE. Burlington,  MA  01803
ContactLindsay Mignone
CorrespondentLindsay Mignone
INTEGRA BURLINGTON MA, INC. 22 TERRY AVE. Burlington,  MA  01803
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-02
Decision Date2012-02-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10381780039495 K113570 000

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