SPIRA-C Integrated Fixation System

Intervertebral Fusion Device With Integrated Fixation, Cervical

Camber Spine Technologies

The following data is part of a premarket notification filed by Camber Spine Technologies with the FDA for Spira-c Integrated Fixation System.

Pre-market Notification Details

Device IDK193153
510k NumberK193153
Device Name:SPIRA-C Integrated Fixation System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant Camber Spine Technologies 501 Allendale Road King Of Prussia,  PA  19406
ContactDaniel Pontecorvo
CorrespondentJustin Eggleton
Mcra, Llc 1050 K Street NW Suite 1000 Washington,  DC  20001
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-13
Decision Date2020-04-24

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