uCerv Flux-C 3D Porous Titanium Cervical Interbody— 510(k) K241396

Name: FDA 510(k) clearance K241396
Creator: U.S. Food and Drug Administration
Published: 2024-05-23

Substantially Equivalent

Ulrich Medical USA, Inc.

FDA 510(k) clearance K241396 for uCerv Flux-C 3D Porous Titanium Cervical Interbody, Substantially Equivalent on 2024-05-23. Applicant: Ulrich Medical USA, Inc.. Device class: 2.

Clearance details

Applicant: Ulrich Medical USA, Inc.
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2024-05-16
Decision date: 2024-05-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Plano, TX, US

Download summary PDF View on FDA.gov ↗

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K254130 — C.A. Medical Interbody Fusion System2026-07-08

More clearances from Ulrich Medical USA, Inc.

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K252087 — Navigation Module of the Cortium® System2026-02-03
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K240515 — uNion® MAX Cervical Plate System2024-03-18

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.