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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, spondylolisthesis spinal fixation
510(k) Number K980761
Device Name SYNTHES SPINE PEDIATRIC ROD SYSTEM
Applicant
SYNTHES SPINE
P.O. BOX 0548
1690 RUSSELL ROAD
PAOLI,  PA  19301
Applicant Contact BARRY E SANDS
Correspondent
SYNTHES SPINE
P.O. BOX 0548
1690 RUSSELL ROAD
PAOLI,  PA  19301
Correspondent Contact BARRY E SANDS
Regulation Number888.3070
Classification Product Code
MNH  
Date Received02/27/1998
Decision Date 08/04/1998
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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