Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage— 510(k) K212792

Name: FDA 510(k) clearance K212792
Creator: U.S. Food and Drug Administration
Published: 2021-09-23

Substantially Equivalent

Medynus, Inc.

FDA 510(k) clearance K212792 for Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage, Substantially Equivalent on 2021-09-23. Applicant: Medynus, Inc.. Device class: 2.

Clearance details

Applicant: Medynus, Inc.
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2021-09-01
Decision date: 2021-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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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.