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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 K261279
Device Name DeltaNEC Interbody System
Applicant
Nexus Spine
2825 E. Cottonwood Pkwy.
Suite 330
Salt Lake City,  UT  84121
Applicant Contact Jared Crocker
Correspondent
MRC Global
9160 Hwy. 64 Suite 12
P.O. Box 330
Lakeland,  TN  38002
Correspondent Contact Jen McBride
Regulation Number888.3080
Classification Product Code
OVE  
Date Received04/17/2026
Decision Date 06/22/2026
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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