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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 K894472
Device Name CROSS ROUND & SQUARE SPINAL RODS & DIST. SPINAL
Applicant
Buckman Co., Inc.
921 Calle Verde
Martinez,  CA  94553
Applicant Contact BROMM, R.N.
Correspondent
Buckman Co., Inc.
921 Calle Verde
Martinez,  CA  94553
Correspondent Contact BROMM, R.N.
Regulation Number888.3050
Classification Product Code
KWP  
Date Received07/18/1989
Decision Date 10/10/1989
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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