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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 Integrated Fixation, Cervical
510(k) Number K190885
Device Name Elevation Spine Saber-C System
Applicant
Elevation Spine
2600 Garden Rd. Suite 330
Monterey,  CA  93940
Applicant Contact Charlie Gilbride
Correspondent
Coorstek Medical
560 W. Golf Course Rd.
Providence,  UT  84332
Correspondent Contact Steve Brown
Regulation Number888.3080
Classification Product Code
OVE  
Subsequent Product Codes
KWQ   ODP  
Date Received04/04/2019
Decision Date 08/07/2019
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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