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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 K955864
Device Name J.B. S. C1-C2 CLAMP
Applicant
J.B.S., S.A.
204 E Blithedale Ave.
Mill Valley,  CA  94941
Applicant Contact RICHARD DI MAIO
Correspondent
J.B.S., S.A.
204 E Blithedale Ave.
Mill Valley,  CA  94941
Correspondent Contact RICHARD DI MAIO
Regulation Number888.3050
Classification Product Code
KWP  
Date Received12/27/1995
Decision Date 03/15/1996
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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