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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 Intervertebral Body
510(k) Number K950209
Device Name J.B.S. ANTERIOR SPINE SYSTEM(R)
Applicant
J.B.S. (Usa), Inc.
553 Pilgrim Dr., #A-1
Foster City,  CA  94404
Applicant Contact HARTMUT H LOCH
Correspondent
J.B.S. (Usa), Inc.
553 Pilgrim Dr., #A-1
Foster City,  CA  94404
Correspondent Contact HARTMUT H LOCH
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received01/19/1995
Decision Date 10/11/1995
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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