BIOMET VARIABLE LOCKING PLATE SYSTEM

Device Classification Name

plate, fixation, bone

510(k) Number K071325
Device Name BIOMET VARIABLE LOCKING PLATE SYSTEM
Applicant
BIOMET TRAUMA
p.o. box 587
warsaw, 
IN 
46581 -0587

Applicant Contact susan alexander
Correspondent
BIOMET TRAUMA
p.o. box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact susan alexander
Regulation Number 888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received 05/10/2007
Decision Date 07/26/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No