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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 K181140
Device Name Axis Chena Cervical PEEK Spacer System
Applicant
Axis Orthopaedics
34355 Poppy Wood St.
Soldotna,  AK  99669
Applicant Contact Craig Wilcox
Correspondent
CoorsTek Medical
560 W. Golf Course Rd.
Providence,  UT  84332
Correspondent Contact Steve Brown
Regulation Number888.3080
Classification Product Code
ODP  
Date Received04/30/2018
Decision Date 11/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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