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Irix-C Cervical Integrated Fusion System

by X-Spine Systems, Inc. 510(k)

Active United States

510(k) K131951

Overview

The Irix-C Cervical Integrated Fusion System is a stand-alone cervical intervertebral fusion device. It consists of an integrated endoskeleton surrounded by an outer PEEK ring and two screws. It is intended for spinal fusion procedures at one level (C3-T1 inclusive) in skeletally mature patients for the treatment of degenerative disc disease.

The device is supplied for use in surgical settings and requires standard incision and tissue retraction for implantation. It is provided as a sterile, single-use implant. Storage and handling should follow manufacturer guidelines. The device received FDA 510(k) clearance under K131951 with product code OVE and was determined to be substantially equivalent to a predicate device.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK131951 Date14 Aug 2013ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
OVE
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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