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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K043410
Device Name EPIPHYSIS SCREW
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 Number888.3040
Classification Product Code
HWC  
Date Received12/10/2004
Decision Date 02/24/2005
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
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