SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES


Device Classification Name

plate, fixation, bone

510(k) Number K080522
Device Name SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES
Applicant
SYNTHES (USA)
1301 goshen pkwy
west chester, 
PA 
19380

Applicant Contact sheri l musgnung
Correspondent
SYNTHES (USA)
1301 goshen pkwy
west chester, 
PA 
19380

Correspodent Contact sheri l musgnung
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 02/26/2008
Decision Date 05/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No