DISTAL HUMERAL PLATES WITH ANGULAR STABILITY


Device Classification Name

plate, fixation, bone

510(k) Number K080184
Device Name DISTAL HUMERAL PLATES WITH ANGULAR STABILITY
Applicant
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH
3150 e. 200th st.
prior lake, 
MN 
55372

Applicant Contact al lippinocott
Correspondent
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH
3150 e. 200th st.
prior lake, 
MN 
55372

Correspodent Contact al lippinocott
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 01/25/2008
Decision Date 03/26/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No