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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, spinal pedicle fixation
510(k) Number K982987
Device Name SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM
Applicant
SYNTHES SPINE
P.O. BOX 0548
1690 RUSSELL ROAD
PAOLI,  PA  19301
Applicant Contact JONATHAN M GILBERT
Correspondent
SYNTHES SPINE
P.O. BOX 0548
1690 RUSSELL ROAD
PAOLI,  PA  19301
Correspondent Contact JONATHAN M GILBERT
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received08/26/1998
Decision Date 10/21/1998
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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