Coveris Cervical Cage System

Intervertebral Fusion Device With Bone Graft, Cervical

Camber Spine Technologies

The following data is part of a premarket notification filed by Camber Spine Technologies with the FDA for Coveris Cervical Cage System.

Pre-market Notification Details

Device IDK170550
510k NumberK170550
Device Name:Coveris Cervical Cage System
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant Camber Spine Technologies 418 E. Lancaster Avenue Wayne,  PA  19087
ContactRyan Gaffney
CorrespondentMargeaux Rogers
MCRA, LLC 1050 K Street NW Suite 1000 Washington,  DC  20001
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-24
Decision Date2017-07-13
Summary:summary

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