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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact AL LIPPINCOTT
Regulation Number888.3030
Classification Product Code
JDS  
Subsequent Product Codes
HSB   HWC  
Date Received03/12/2008
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
Predetermined Change
Control Plan Authorized		 No
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