Camber Sacroiliac (SI) Fixation System

Sacroiliac Joint Fixation

Camber Spine Technologies, LLC

The following data is part of a premarket notification filed by Camber Spine Technologies, Llc with the FDA for Camber Sacroiliac (si) Fixation System.

Pre-market Notification Details

Device IDK203503
510k NumberK203503
Device Name:Camber Sacroiliac (SI) Fixation System
ClassificationSacroiliac Joint Fixation
Applicant Camber Spine Technologies, LLC 501 Allendale Road King Of Prussia,  PA  19604
ContactDaniel A. Pontecorvo
CorrespondentChristine Scifert
MRC Global 9085 East Mineral Circle, Suite 110 Centennial,  CO  80112
Product CodeOUR  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-30
Decision Date2022-09-02

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