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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 K982322
Device Name SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEM
Applicant
Synthes (Usa)
1303 Goshen Pkwy.
West Chester,  PA  19380
Applicant Contact JONATHAN M GILBERT
Correspondent
Synthes (Usa)
1303 Goshen Pkwy.
West Chester,  PA  19380
Correspondent Contact JONATHAN M GILBERT
Regulation Number888.3050
Classification Product Code
KWP  
Date Received07/02/1998
Decision Date 11/25/1998
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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