DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K002775
Device Name DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM
Original Applicant
HAND INNOVATIONS, INC.
19526 east lake dr.
miami, 
FL 
33015

Original Contact al weisenborn
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 09/06/2000
Decision Date 12/05/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No