DISTAL RADIUS FRACTURE REPAIR SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K023007
Device Name DISTAL RADIUS FRACTURE REPAIR SYSTEM
Original Applicant
HAND INNOVATIONS, INC.
510 stonemont dr.
weston, 
FL 
33326

Original Contact richard d bliss
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 09/09/2002
Decision Date 12/05/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No