IRIX-A Lumbar Integrated Fusion System— 510(k) K171567

Clearance details

Applicant

X-Spine Systems, Inc.

Product code

Code OVD

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2017-05-30

Decision date

2017-08-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Miamisburg, OH, US

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• K260810 — Anteralign LS coverplate2026-06-10

• K173832 — InTice-C Porous Ti Cervical Interbody System2018-05-17
• K180153 — X-spine Cortical Bone Screw System2018-03-15
• K170119 — Calix Lumbar Spinal Implant System2017-09-29
• K171075 — Calix-C Cervical Interbody Spacer2017-08-01
• K170224 — Spider Cervical Plating System2017-07-06

Death

5

Injury

495

Total

500

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1177-2025 — Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8¿, 19mm, PC, (STERILE))Class II·Ongoing·XTANT Medical Holdings, Inc·20250103

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171567.