LOWER EXTREMITY EXTERNAL FIXATION – EXPANDED INDICATIONS


Device Classification Name

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

510(k) Number K081244
Device Name LOWER EXTREMITY EXTERNAL FIXATION – EXPANDED INDICATIONS
Applicant
BIOMET TRAUMA
p.o. box 587
warsaw, 
IN 
46581 -0587

Applicant Contact patricia s beres
Correspondent
BIOMET TRAUMA
p.o. box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact patricia s beres
Regulation Number 888.3030
Classification Product Code
KTT  
Date Received 05/01/2008
Decision Date 07/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No