SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES


Device Classification Name

plate, fixation, bone

510(k) Number K030597
Device Name SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES
Applicant
SYNTHES (USA)
p.o. box 1766
1690 russell road
paoli, 
PA 
19301 -1222

Applicant Contact lisa m boyle
Correspondent
SYNTHES (USA)
p.o. box 1766
1690 russell road
paoli, 
PA 
19301 -1222

Correspodent Contact lisa m boyle
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 02/25/2003
Decision Date 03/20/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No