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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 K252240
Device Name Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System
Applicant
Spectrum Spine
20 Harmony Ct.
Jasper,  GA  30143
Applicant Contact James Robinson
Correspondent
Mcra, LLC
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Sarah Welsh
Regulation Number888.3080
Classification Product Code
ODP  
Date Received07/17/2025
Decision Date 03/30/2026
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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