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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 K955927
Device Name BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION)
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  
Subsequent Product Code
MNH  
Date Received12/22/1995
Decision Date 03/13/1996
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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