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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 K953599
Device Name CLAMP ASSEMBLY
Applicant
J.B.S., S.A.
6311 Shorewood Ct.
Pleasenton,  CA  94588
Applicant Contact LISA BURNS
Correspondent
J.B.S., S.A.
6311 Shorewood Ct.
Pleasenton,  CA  94588
Correspondent Contact LISA BURNS
Regulation Number888.3050
Classification Product Code
KWP  
Date Received08/02/1995
Decision Date 12/19/1995
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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