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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 K895296
Device Name SELBY II INSTRUMENTATION
Applicant
Advanced Spine Fixation
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Applicant Contact KAHAN
Correspondent
Advanced Spine Fixation
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Correspondent Contact KAHAN
Regulation Number888.3050
Classification Product Code
KWP  
Date Received08/25/1989
Decision Date 03/20/1990
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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