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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 K962757
Device Name J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP
Applicant
J.B.S., S.A.
6311 Shorewood Ct.
Pleasenton,  CA  94588
Applicant Contact LIZA BURNS
Correspondent
J.B.S., S.A.
6311 Shorewood Ct.
Pleasenton,  CA  94588
Correspondent Contact LIZA BURNS
Regulation Number888.3070
Classification Product Code
MNH  
Date Received07/16/1996
Decision Date 09/25/1996
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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