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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K093868
Device Name I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM
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
HRS  
Subsequent Product Code
HWC  
Date Received12/17/2009
Decision Date 08/05/2010
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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