SYNTHES TOMOFIX OSTEOTOMY SYSTEM


Device Classification Name

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

510(k) Number K023941
Device Name SYNTHES TOMOFIX OSTEOTOMY 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
KTT  
Date Received 11/26/2002
Decision Date 01/23/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls