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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 K252686
Device Name EffortMed PEEK Cages & Corpectomy Cages
Applicant
Effortmed, LLC
4766 NW 91st Way
Coral Springs,  FL  33067
Applicant Contact Steven Brown
Correspondent
The OrthoMedix Group, Inc.
4314 W. 3800 S.
West Haven,  UT  84404
Correspondent Contact J.D. Webb
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Codes
MAX   MQP   PLR  
Date Received08/26/2025
Decision Date 11/21/2025
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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