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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with bone graft, cervical
510(k) Number K120345
Device Name HONOUR SPACER SYSTEM
Applicant
NEXXT SPINE LLC
PO BOX 566
CHESTERLAND,  OH  44026
Applicant Contact KAREN E WARDEN
Correspondent
NEXXT SPINE LLC
PO BOX 566
CHESTERLAND,  OH  44026
Correspondent Contact KAREN E WARDEN
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Codes
MAX   MQP  
Date Received02/03/2012
Decision Date 06/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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