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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 K940631
Device Name CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM
Applicant
CROSS MEDICAL PRODUCTS, INC.
C/O BUCKMAN CO., INC.
1000 BURNETT AVENUE, STE. 450
CONCORD,  CA  94520
Applicant Contact DAVID W SCHLERF
Correspondent
CROSS MEDICAL PRODUCTS, INC.
C/O BUCKMAN CO., INC.
1000 BURNETT AVENUE, STE. 450
CONCORD,  CA  94520
Correspondent Contact DAVID W SCHLERF
Regulation Number888.3070
Classification Product Code
MNH  
Date Received02/14/1994
Decision Date 07/13/1995
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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