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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
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