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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 K950099
Device Name SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM
Applicant
Buckman Co., Inc.
1000 Burnett Ave., Suite 450
Concord,  CA  94520
Applicant Contact DAVID W SCHLERF
Correspondent
Buckman Co., Inc.
1000 Burnett Ave., Suite 450
Concord,  CA  94520
Correspondent Contact DAVID W SCHLERF
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
KWP  
Date Received01/10/1995
Decision Date 01/16/1997
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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