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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K964007
Device Name ACROMED CABLE/WIRE PEDICLE SCREW
Applicant
Acromed Corp.
3303 Carnegie Ave.
Cleveland,  OH  44115
Applicant Contact WILLIAM CHRISTIANSON
Correspondent
Acromed Corp.
3303 Carnegie Ave.
Cleveland,  OH  44115
Correspondent Contact WILLIAM CHRISTIANSON
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
KWP  
Date Received10/07/1996
Decision Date 12/16/1996
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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