MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM— 510(k) K090507

Clearance details

Applicant

Ldr Spine USA

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2009-02-25

Decision date

2009-06-25

Decision

Substantially Equivalent

Clearance type

Special

Location

Austin, TX, US

• K261049 — SCALA® TL2026-08-20
• K261430 — TruLift Expandable System2026-07-28
• K253011 — Catalyft PL Expandable Interbody System2026-07-17
• K261020 — Symmetrix L Spinal System2026-07-14
• K253420 — Admiral ACP System +18 more2026-07-01

• K153495 — Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System2016-03-31
• K152137 — FacetBRIDGE System2016-01-25
• K151934 — ROI-C Titanium-Coated Implant System2015-12-07
• K150765 — LDR Spine ROI-C Cervical Cage System2015-09-17
• K110327 — LDR SPINE ROI-A INTERBODY FUSION SYSTEM2011-09-30

Death

13

Injury

1,305

Malfunction

2,885

Total

4,203

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-0045-2017 — ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.Class II·Terminated·LDR Spine USA, Inc.·20160829

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090507.