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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 K983530
Device Name SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM
Applicant
SYNTHES (USA)
1303 GOSHEN PKWY.
WAST CHESTER,  PA  19380
Applicant Contact JONATHAN M GILBERT
Correspondent
SYNTHES (USA)
1303 GOSHEN PKWY.
WAST CHESTER,  PA  19380
Correspondent Contact JONATHAN M GILBERT
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received10/08/1998
Decision Date 12/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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