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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 Interlaminal
510(k) Number K980358
Device Name SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM
Applicant
Synthes (Usa)
P.O. Box 1766
1690 Russell Rd.
Paoli,  PA  19301
Applicant Contact BARRY E SANDS
Correspondent
Synthes (Usa)
P.O. Box 1766
1690 Russell Rd.
Paoli,  PA  19301
Correspondent Contact BARRY E SANDS
Regulation Number888.3050
Classification Product Code
KWP  
Date Received01/29/1998
Decision Date 04/16/1998
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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