RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR


Device Classification Name

pin, fixation, threaded

510(k) Number K021182
Device Name RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR
Original Applicant
BIOMET, INC.
56 east bell dr.
warsaw, 
IN 
46581 -0587

Original Contact tracy j bickel
Regulation Number 888.3040
Classification Product Code
JDW  
Date Received 04/15/2002
Decision Date 05/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No