RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM


Device Classification Name

appliance, fixation, nail/blade/plate combination, multiple component

510(k) Number K110965
Device Name RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM
Applicant
RENOVIS SURGICAL TECHNOLOGIES, LLC
11234 el camino real
suite 200
san diego, 
CA 
92130

Applicant Contact david j collette, md
Correspondent
RENOVIS SURGICAL TECHNOLOGIES, LLC
11234 el camino real
suite 200
san diego, 
CA 
92130

Correspodent Contact david j collette, md
Regulation Number 888.3030
Classification Product Code
KTT  
Date Received 04/06/2011
Decision Date 05/11/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No