INTEGRA(TM) CUSA NXT(TM) BONE TIPS


Device Classification Name

instrument, ultrasonic surgical

510(k) Number K111741
Device Name INTEGRA(TM) CUSA NXT(TM) BONE TIPS
Applicant
INTEGRA BURLINGTON MA, INC. (FORMERLY INTEGRA RADI
22 terry ave
burlington, 
MA 
01803

Applicant Contact kevin j o’connell
Correspondent
INTEGRA BURLINGTON MA, INC. (FORMERLY INTEGRA RADI
22 terry ave
burlington, 
MA 
01803

Correspodent Contact kevin j o’connell
Classification Product Code
LFL  
Date Received 06/21/2011
Decision Date 08/23/2011
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No