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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K232256
Device Name Alcantara Thoracolumbar Plate System
Applicant
Camber Spine Technologies, LLC
501 Allendale Rd.
King Of Prussia,  PA  19406
Applicant Contact Brooks McAdam
Correspondent
MRC Global, LLC
9085 E. Mineral Circle,
Suite 110
Centennial,  CO  80112
Correspondent Contact Christine Scifert
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received07/28/2023
Decision Date 04/16/2024
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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