OSTEOMED HAND FUSION SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K111419
Device Name OSTEOMED HAND FUSION SYSTEM
Applicant
OSTEOMED L.P.
3885 arapaho rd.
addison, 
TX 
75001

Applicant Contact suzanne cheang
Correspondent
OSTEOMED L.P.
3885 arapaho rd.
addison, 
TX 
75001

Correspodent Contact suzanne cheang
Regulation Number 888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received 05/20/2011
Decision Date 10/07/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No