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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 Integrated Fixation, Cervical
510(k) Number K223837
Device Name SPIRA®-C Integrated Fixation System
Applicant
Camber Spine Technologies
501 Allendale Rd.
King Of Prussia,  PA  19406
Applicant Contact Brooks McAdam
Correspondent
MRC Global, LLC
9085 E. Mineral Cir
Suite 110
Centennial,  CO  80112
Correspondent Contact Christine Scifert
Regulation Number888.3080
Classification Product Code
OVE  
Date Received12/22/2022
Decision Date 03/22/2023
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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