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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 Intervertebral Body
510(k) Number K950011
Device Name COHORT(TM) ANTERIOR PLATE SYSTEM (APS)
Applicant
Cohort Medical Products Group, Inc.
25590 Seaboard Ln.
Hayward,  CA  94545
Applicant Contact MARK URBSNSKI
Correspondent
Cohort Medical Products Group, Inc.
25590 Seaboard Ln.
Hayward,  CA  94545
Correspondent Contact MARK URBSNSKI
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received01/03/1995
Decision Date 11/06/1995
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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