ROI-C Titanium-Coated Implant System— 510(k) K151934

Substantially Equivalent

Ldr Spine USA

FDA 510(k) clearance K151934 for ROI-C Titanium-Coated Implant System, Substantially Equivalent on 2015-12-07. Applicant: Ldr Spine USA.

Clearance details

Applicant: Ldr Spine USA
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2015-07-14
Decision date: 2015-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.