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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sacroiliac Joint Fixation
510(k) Number K203503
Device Name Camber Sacroiliac (SI) Fixation System
Applicant
Camber Spine Technologies, LLC
501 Allendale Rd.
King Of Prussia,  PA  19604
Applicant Contact Daniel A. Pontecorvo
Correspondent
MRC Global
9085 E. Mineral Cir., Suite 110
Centennial,,  CO  80112
Correspondent Contact Christine Scifert
Regulation Number888.3040
Classification Product Code
OUR  
Date Received11/30/2020
Decision Date 09/02/2022
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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