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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, Non-Spinal, Metallic
510(k) Number K051642
Device Name FR.O.H. CALCANEUS REPAIR 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
NDF  
Subsequent Product Code
NDJ  
Date Received06/20/2005
Decision Date 08/22/2005
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
Recalls CDRH Recalls
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