SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES


Device Classification Name

plate, fixation, bone

510(k) Number K081353
Device Name SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES
Applicant
SYNTHES (USA)
1301 goshen pkwy
west chester, 
PA 
19380

Applicant Contact karl j nittinger
Correspondent
SYNTHES (USA)
1301 goshen pkwy
west chester, 
PA 
19380

Correspodent Contact karl j nittinger
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 05/14/2008
Decision Date 07/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No