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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, spinal interlaminal
510(k) Number K041808
Device Name ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
Applicant
ENDIUS, INC.
23 WEST BACON ST.
PLAINVILLE,  MA  02762
Applicant Contact CHRISTINE KUNTZ-NASSIF
Correspondent
ENDIUS, INC.
23 WEST BACON ST.
PLAINVILLE,  MA  02762
Correspondent Contact CHRISTINE KUNTZ-NASSIF
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI   NKB  
Date Received07/06/2004
Decision Date 10/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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