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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ultrasonic Surgical
510(k) Number K113570
Device Name INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP
Applicant
Integra Burlington Ma, Inc.
22 Terry Ave.
Burlington,  MA  01803
Applicant Contact LINDSAY MIGNONE
Correspondent
Integra Burlington Ma, Inc.
22 Terry Ave.
Burlington,  MA  01803
Correspondent Contact LINDSAY MIGNONE
Classification Product Code
LFL  
Date Received12/02/2011
Decision Date 02/22/2012
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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