Irix-C Cervical Integrated Fusion System

Intervertebral Fusion Device With Integrated Fixation, Cervical

X-SPINE SYSTEMS, INC.

The following data is part of a premarket notification filed by X-spine Systems, Inc. with the FDA for Irix-c Cervical Integrated Fusion System.

Pre-market Notification Details

Device IDK162944
510k NumberK162944
Device Name:Irix-C Cervical Integrated Fusion System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant X-SPINE SYSTEMS, INC. 452 ALEXANDERSVILLE RD. Miamisburg,  OH  45342
ContactKriss Andersson
CorrespondentKriss Andersson
X-SPINE SYSTEMS, INC. 452 ALEXANDERSVILLE RD. Miamisburg,  OH  45342
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-21
Decision Date2016-11-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M697X06637211 K162944 000
M697X0663512ST1 K162944 000
M697X0663514SD1 K162944 000
M697X0663514ST1 K162944 000
M697X0663516SD1 K162944 000
M697X0663516ST1 K162944 000
M697X0663518ST1 K162944 000
M697X0663520SD1 K162944 000
M697X0663520ST1 K162944 000
M697X06637131 K162944 000
M697X06637151 K162944 000
M697X06637171 K162944 000
M697X06637191 K162944 000
M697X0663512SD1 K162944 000

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