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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 K945435
Device Name BRYAN POSTERIOR SPINAL FIXATOR (BPSF)
Applicant
Arcan Orthopaedic Corp.
3903 Harrison Blvd.
Suite 400-E
Ogden,  UT  84403
Applicant Contact DONALD W BRYAN
Correspondent
Arcan Orthopaedic Corp.
3903 Harrison Blvd.
Suite 400-E
Ogden,  UT  84403
Correspondent Contact DONALD W BRYAN
Regulation Number888.3050
Classification Product Code
KWP  
Date Received10/07/1994
Decision Date 05/31/1995
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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