Reliance Spinal Screw System— 510(k) K162066

Name: FDA 510(k) clearance K162066
Creator: U.S. Food and Drug Administration
Published: 2016-12-02

Substantially Equivalent

Reliance Medical Systems, LLC

FDA 510(k) clearance K162066 for Reliance Spinal Screw System, Substantially Equivalent on 2016-12-02. Applicant: Reliance Medical Systems, LLC. Device class: 2.

Clearance details

Applicant: Reliance Medical Systems, LLC
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2016-07-26
Decision date: 2016-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bountiful, UT, US

Download summary PDF View on FDA.gov ↗

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K162189 — ANAX 5.5 Spinal System2016-08-30
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More clearances from Reliance Medical Systems, LLC

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K202266 — Reliance Cervical IBF System2022-03-29
K210874 — Reliance Spinal Screw System2021-05-13
K183049 — Reliance Lumbar IBF System2019-02-15
K173283 — Reliance Lumbar IBF System2018-01-19
K173102 — Reliance Cervical IBF System2017-12-29

Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.