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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Cement Restrictor
510(k) Number K012278
Device Name THEKEN SMALL CEMENT RESTRICTOR
Applicant
Theken Surgical,Llc
1100 Nola Ave.
Barberton,  OH  44203
Applicant Contact RANDY THEKEN
Correspondent
Theken Surgical,Llc
1100 Nola Ave.
Barberton,  OH  44203
Correspondent Contact RANDY THEKEN
Regulation Number878.3300
Classification Product Code
JDK  
Date Received07/19/2001
Decision Date 10/17/2001
Decision SE - With Limitations (SESU)
Regulation Medical Specialty General & Plastic Surgery
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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