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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Fixation, Proximal Femoral, Implant
510(k) Number K953607
Device Name TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS)
Applicant
Synthes (Usa)
1690 Russell Rd.
P.O. Box 1766
Paoli,  PA  19301
Applicant Contact ANGELA J SILVESTRI
Correspondent
Synthes (Usa)
1690 Russell Rd.
P.O. Box 1766
Paoli,  PA  19301
Correspondent Contact ANGELA J SILVESTRI
Regulation Number888.3030
Classification Product Code
JDO  
Date Received08/02/1995
Decision Date 03/08/1996
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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