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IRIX-A Lumbar Integrated Fusion System

by X-Spine Systems, Inc. 2 variants

510(k) K171567

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK171567 Date28 Aug 2017ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1177-2025 FDA Class II initiated 3 Jan 2025

    Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

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