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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 K970955
Device Name ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM
Applicant
Acromed Corp.
3303 Carnegie Ave.
Cleveland,  OH  44115
Applicant Contact SALLY LEVINE
Correspondent
Acromed Corp.
3303 Carnegie Ave.
Cleveland,  OH  44115
Correspondent Contact SALLY LEVINE
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/17/1997
Decision Date 06/11/1997
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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