2MM PEDIATRIC FLEX NAIL


Device Classification Name

pin, fixation, smooth

510(k) Number K022531
Device Name 2MM PEDIATRIC FLEX NAIL
Original Applicant
BIOMET, INC.
56 bell dr.
po box 587
warsaw, 
IN 
46581 -0587

Original Contact tracy j bickel
Regulation Number 888.3040
Classification Product Code
HTY  
Date Received 07/31/2002
Decision Date 08/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No