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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 K992739
Device Name CLICK'X
Applicant
SYNTHES SPINE
P.O. BOX 0548
1690 RUSSELL ROAD
PAOLI,  PA  19301
Applicant Contact JONATHAN M GILBERT
Correspondent
SYNTHES SPINE
P.O. BOX 0548
1690 RUSSELL ROAD
PAOLI,  PA  19301
Correspondent Contact JONATHAN M GILBERT
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received08/16/1999
Decision Date 02/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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