WRIST FUSION PLATE


Device Classification Name

plate, fixation, bone

510(k) Number K021321
Device Name WRIST FUSION PLATE
Original Applicant
ACUMED, INC.
5885 nw cornelius pass rd.
hillsboro, 
OR 
97124 -9432

Original Contact carrie mcmichael
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 04/25/2002
Decision Date 07/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No