Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Irix-C Cervical Integrated Fusion System

K-Number: K162944 · 2016-11-07

ApplicantX-Spine Systems, Inc.
Decision Date2016-11-07
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Irix-C Cervical Integrated Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2016-11-07 under 510(k) number K162944. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Irix-C Cervical Integrated Fusion System?

Irix-C Cervical Integrated Fusion System is a medical device that received FDA 510(k) clearance on 2016-11-07. The listed applicant is X-Spine Systems, Inc.. The 510(k) number is K162944.

When did Irix-C Cervical Integrated Fusion System receive FDA 510(k) clearance?

Irix-C Cervical Integrated Fusion System received FDA 510(k) clearance on 2016-11-07, under 510(k) number K162944.

Who is the listed applicant for Irix-C Cervical Integrated Fusion System?

The FDA 510(k) record lists X-Spine Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Irix-C Cervical Integrated Fusion System?

The FDA product code for Irix-C Cervical Integrated Fusion System is OVE.

Other records listing X-Spine Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173832InTice™-C Porous Ti Cervical Interbody SystemK180153X-spine Cortical Bone Screw SystemK170119Calix Lumbar Spinal Implant SystemK171567IRIX-A Lumbar Integrated Fusion SystemK171075Calix-C Cervical Interbody SpacerK170224Spider Cervical Plating System

View all 11 devices →

Related Devices (Code: OVE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑