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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 K022791
Device Name SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM
Applicant
Synthes (Usa)
1690 Russell Rd.
Paoli,  PA  19301
Applicant Contact VIKKI M HOFFMAN
Correspondent
Synthes (Usa)
1690 Russell Rd.
Paoli,  PA  19301
Correspondent Contact VIKKI M HOFFMAN
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received08/22/2002
Decision Date 11/13/2002
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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