RIGEL PEEK Anterior Cervical Interbody Fusion System— 510(k) K190618

Substantially Equivalent

MiRus, LLC

FDA 510(k) clearance K190618 for RIGEL PEEK Anterior Cervical Interbody Fusion System, Substantially Equivalent on 2019-06-06. Applicant: MiRus, LLC.

Clearance details

Applicant: MiRus, LLC
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2019-03-11
Decision date: 2019-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

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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.