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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K953416
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 Number888.3070
Classification Product Code
MNH  
Date Received07/10/1995
Decision Date 10/03/1995
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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