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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 K854770
Device Name MARTIN LAMINAR OSTEOSYNTHESIS SYSTEM
Applicant
Advanced Biosearch Assn.
1700 Rockville Pike
Suite 320
Rockville,  MD  20852
Applicant Contact JO LYONS
Correspondent
Advanced Biosearch Assn.
1700 Rockville Pike
Suite 320
Rockville,  MD  20852
Correspondent Contact JO LYONS
Regulation Number888.3050
Classification Product Code
KWP  
Date Received11/27/1985
Decision Date 02/11/1986
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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