CONNEXX LOCKING TIBIA NAIL


Device Classification Name

nail, fixation, bone

510(k) Number K080706
Device Name CONNEXX LOCKING TIBIA NAIL
Applicant
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH
3150 e. 200th st.
prior lake, 
MN 
55372

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

Correspodent Contact al lippincott
Regulation Number 888.3030
Classification Product Code
JDS  
Subsequent Product Codes
HSB   HWC  
Date Received 03/12/2008
Decision Date 06/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No