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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 K254130
Device Name C.A. Medical Interbody Fusion System
Applicant
C.A. Medical, LLC
431 E. State Hwy. 114
Suite 160
Southlake,  TX  76092
Applicant Contact Harold Childs
Correspondent
The OrthoMedix Group, Inc.
4313 W. 3800 S.
West Haven,  UT  84401
Correspondent Contact J.D. Webb
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MAX  
Date Received12/22/2025
Decision Date 07/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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