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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 K951172
Device Name TITANIUM LOW PROFILE CROSS BAR
Applicant
Advanced Spine Fixation Systems, Inc.
11095 Knott Ave.
Suite L
Cypress,  CA  90630
Applicant Contact JAMES A RINNER
Correspondent
Advanced Spine Fixation Systems, Inc.
11095 Knott Ave.
Suite L
Cypress,  CA  90630
Correspondent Contact JAMES A RINNER
Regulation Number888.3070
Classification Product Code
MNH  
Date Received03/15/1995
Decision Date 07/25/1995
Decision Substantially Equivalent (SESE)
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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