SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K023802
Device Name SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM
Original Applicant
SYNTHES (USA)
1690 russell rd.
post office box 1766
paoli, 
PA 
19301

Original Contact lisa m boyle
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 11/14/2002
Decision Date 01/28/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No