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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, spinal pedicle fixation
510(k) Number K994121
Device Name SMALL STATURE USS
Applicant
SYNTHES (USA)
P.O. BOX 1766
1690 RUSSELL ROAD
PAOLI,  PA  19301 -1222
Applicant Contact JONATHAN M GILBERT
Correspondent
SYNTHES (USA)
P.O. BOX 1766
1690 RUSSELL ROAD
PAOLI,  PA  19301 -1222
Correspondent Contact JONATHAN M GILBERT
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received12/06/1999
Decision Date 10/17/2000
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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