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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 Bone Graft, Cervical
510(k) Number K250764
Device Name SpineLinc Anterior Cervical Implant System
Applicant
Lincotek Medical
3110 Stage Post Dr.
Suite 117
Bartlett,  TN  38133
Applicant Contact Troy Walters
Correspondent
MRC Global
9085 E. Mineral Circle,
Suite 110
Centennial,  CO  80112
Correspondent Contact Christine Scifert
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Codes
KWQ   OVE  
Date Received03/13/2025
Decision Date 12/05/2025
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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