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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 K942432
Device Name J.B.S. CERVICAL SPINE SYSTEM
Applicant
J.B.S., S.A.
391 Menhaden Ct.
Foster City,  CA  94404
Applicant Contact HARTMUT H LOCH
Correspondent
J.B.S., S.A.
391 Menhaden Ct.
Foster City,  CA  94404
Correspondent Contact HARTMUT H LOCH
Regulation Number888.3050
Classification Product Code
KWP  
Date Received05/20/1994
Decision Date 07/11/1995
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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