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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K180301
Device Name AXIS 5.5 Lumbar Pedicle Screw System
Applicant
Axis Orthopaedics
34355 Poppy Wood
Soldotna,  AK  99669
Applicant Contact Craig Wilcox
Correspondent
Coorstek Medical
560 W. Golf Course Rd.
Providence,  UT  84332
Correspondent Contact Steve Brown
Regulation Number888.3070
Classification Product Code
NKB  
Date Received02/02/2018
Decision Date 04/10/2018
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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