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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
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