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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, Lumbar
510(k) Number K261408
Device Name SABER-XA System
Applicant
Elevation Spine
2511 Garden Rd.
Suite B125
Monteray,  CA  93940
Applicant Contact John Kirwan
Correspondent
MRC Global, LLC
9160 Hwy. 64 Suite 12
P.O. Box 330
Lakeland,  TN  38002
Correspondent Contact Jen McBride
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Codes
KWQ   MAX  
Date Received04/30/2026
Decision Date 08/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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