BIOMET PHOENIX ANKLE NAIL SYSTEM


Device Classification Name

rod, fixation, intramedullary and accessories

510(k) Number K081243
Device Name BIOMET PHOENIX ANKLE NAIL 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 888.3020
Classification Product Code
HSB  
Date Received 05/01/2008
Decision Date 06/27/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No