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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 K920102
Device Name THE SELBY SYSTEM
Applicant
Advanced Spine Fixation Systems, Inc.
Patricia B. Shrader
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact & HARTSON
Correspondent
Advanced Spine Fixation Systems, Inc.
Patricia B. Shrader
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact & HARTSON
Regulation Number888.3050
Classification Product Code
KWP  
Date Received01/09/1992
Decision Date 05/05/1992
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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