TEMPFIX EXTERNAL FIXATION SYSTEM


Device Classification Name

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

510(k) Number K021933
Device Name TEMPFIX EXTERNAL FIXATION SYSTEM
Original Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw, 
IN 
46581 -0988

Original Contact cheryl k hastings
Regulation Number 888.3030
Classification Product Code
KTT  
Subsequent Product Code
LXT  
Date Received 06/12/2002
Decision Date 08/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No