Reliance Lumbar IBF System— 510(k) K181118

Name: FDA 510(k) clearance K181118
Creator: U.S. Food and Drug Administration
Published: 2019-01-09

Substantially Equivalent

Reliance Medical Systems

FDA 510(k) clearance K181118 for Reliance Lumbar IBF System, Substantially Equivalent on 2019-01-09. Applicant: Reliance Medical Systems. Device class: 2.

Clearance details

Applicant: Reliance Medical Systems
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2018-04-27
Decision date: 2019-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bountiful, UT, US

Download summary PDF View on FDA.gov ↗

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K180687 — Reliance Lumber IBF System2018-05-15
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Adverse events under product code OVD

product code OVD

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 →

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