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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 K991528
Device Name MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR
Applicant
Danek Medical, Inc.
1800 Pyramid Pl
Memphis,  TN  38132
Applicant Contact RICHARD W TREHARNE
Correspondent
Danek Medical, Inc.
1800 Pyramid Pl
Memphis,  TN  38132
Correspondent Contact RICHARD W TREHARNE
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
KWP  
Date Received05/03/1999
Decision Date 05/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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