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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 K924474
Device Name SELBY INSTRUMENTATION
Applicant
Advanced Spine Fixation Systems, Inc.
11730 Seaboard Cir.
Stanton,  CA  90680
Applicant Contact ROBERT S HOWLAND
Correspondent
Advanced Spine Fixation Systems, Inc.
11730 Seaboard Cir.
Stanton,  CA  90680
Correspondent Contact ROBERT S HOWLAND
Regulation Number888.3050
Classification Product Code
KWP  
Date Received09/03/1992
Decision Date 09/21/1993
Decision Substantially Equivalent (SESE)
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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