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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 K010922
Device Name TRI-FIX SPINAL FIXATION SYSTEM
Applicant
ENDIUS, INC.
23 WEST BACON ST.
PLAINVILLE,  MA  02762
Applicant Contact SUSAN FINNERAN
Correspondent
ENDIUS, INC.
23 WEST BACON ST.
PLAINVILLE,  MA  02762
Correspondent Contact SUSAN FINNERAN
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received03/27/2001
Decision Date 06/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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