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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 K001044
Device Name ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM
Applicant
ACME SPINE, LLC.
9980 INDIANA AVE.
UNIT 9
RIVERSIDE,  CA  92503
Applicant Contact TIMOTHY WILLIAMS
Correspondent
ACME SPINE, LLC.
9980 INDIANA AVE.
UNIT 9
RIVERSIDE,  CA  92503
Correspondent Contact TIMOTHY WILLIAMS
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received03/31/2000
Decision Date 11/03/2000
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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