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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, Lumbar
510(k) Number K234077
Device Name SPIRA® Anterior Lumbar Spacers
Applicant
Camber Spine Technologies
501 Allendale Rd.
King Of Prussia,  PA  19406
Applicant Contact Brooks McAdam
Correspondent
MRC Global
9085 E. Mineral Cir., Suite 110
Centennial,,  CO  80112
Correspondent Contact Christine Scifert
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Codes
OVD   PHM  
Date Received12/22/2023
Decision Date 07/12/2024
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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