510(k) K113570

INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP by Integra Burlington Ma, Inc. — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2012
Date Received
December 2, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ultrasonic Surgical
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type