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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 K010658
Device Name MODIFIED USS FRACTURE SYSTEM
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
P.O. BOX 1766
PAOLI,  PA  19301
Applicant Contact JONATHAN GILBERT
Correspondent
SYNTHES (USA)
1690 RUSSELL RD.
P.O. BOX 1766
PAOLI,  PA  19301
Correspondent Contact JONATHAN GILBERT
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   KWQ   MNH  
Date Received03/06/2001
Decision Date 06/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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