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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 K965102
Device Name ACROMED 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  
Date Received12/20/1996
Decision Date 05/08/1997
Decision Substantially Equivalent (SESE)
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
Recalls CDRH Recalls
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