INTEGRA(TM) CUSA NXT(TM) BONE TIPS

Instrument, Ultrasonic Surgical

INTEGRA BURLINGTON MA, INC. (FORMERLY INTEGRA RADI

The following data is part of a premarket notification filed by Integra Burlington Ma, Inc. (formerly Integra Radi with the FDA for Integra(tm) Cusa Nxt(tm) Bone Tips.

Pre-market Notification Details

Device IDK111741
510k NumberK111741
Device Name:INTEGRA(TM) CUSA NXT(TM) BONE TIPS
ClassificationInstrument, Ultrasonic Surgical
Applicant INTEGRA BURLINGTON MA, INC. (FORMERLY INTEGRA RADI 22 Terry Ave Burlington,  MA  01803
ContactKevin J O'connell
CorrespondentKevin J O'connell
INTEGRA BURLINGTON MA, INC. (FORMERLY INTEGRA RADI 22 Terry Ave Burlington,  MA  01803
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-21
Decision Date2011-08-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10381780039471 K111741 000
M269NXT3218EA1 K111741 000

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