TITANIUM ANKLE ARTHRODESIS NAIL


Device Classification Name

rod, fixation, intramedullary and accessories

510(k) Number K021786
Device Name TITANIUM ANKLE ARTHRODESIS NAIL
Original Applicant
BIOMET, INC.
56 east bell dr.
warsaw, 
IN 
46581 -0587

Original Contact lonnie witham
Regulation Number 888.3020
Classification Product Code
HSB  
Date Received 05/30/2002
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