Reliance Cervical IBF System— 510(k) K202266

Name: FDA 510(k) clearance K202266
Creator: U.S. Food and Drug Administration
Published: 2022-03-29

Substantially Equivalent

Reliance Medical Systems, LLC

FDA 510(k) clearance K202266 for Reliance Cervical IBF System, Substantially Equivalent on 2022-03-29. Applicant: Reliance Medical Systems, LLC. Device class: 2.

Clearance details

Applicant: Reliance Medical Systems, LLC
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2020-08-11
Decision date: 2022-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bountiful, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ODP

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K262595 — VariLift-C Cervical Interbody Fusion System2026-08-26
K262489 — BluEX Cervical Expandable Cage System2026-08-18
K253041 — 3d Cage Cervical2026-07-23
K262061 — Tritanium® C Anterior Cervical Cage +16 more2026-07-17
K254130 — C.A. Medical Interbody Fusion System2026-07-08

More clearances from Reliance Medical Systems, LLC

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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
K172489 — Reliance Cervical IBF System2017-09-07

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.