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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K010466
Device Name TETHER ACFS
Applicant
Theken Surgical,Llc
1100 Nola Ave.
Barberton,  OH  44203
Applicant Contact ROBERT THEKEN
Correspondent
Theken Surgical,Llc
1100 Nola Ave.
Barberton,  OH  44203
Correspondent Contact ROBERT THEKEN
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received02/16/2001
Decision Date 05/16/2001
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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