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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 K952298
Device Name SPINAL PEDICLE SCREW, FIXATION, APPLIANCE
Applicant
J.B.S., S.A.
553 Pilgrim Dr., #A-1
Foster City,  CA  94404
Applicant Contact RICHARD DI MAIO
Correspondent
J.B.S., S.A.
553 Pilgrim Dr., #A-1
Foster City,  CA  94404
Correspondent Contact RICHARD DI MAIO
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
KWP  
Date Received05/16/1995
Decision Date 12/13/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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