Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

uCerv Flux™-C 3D Porous Titanium Cervical Interbody

K-Number: K241396 · 2024-05-23

ApplicantUlrich Medical USA, Inc.
Decision Date2024-05-23
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

uCerv Flux™-C 3D Porous Titanium Cervical Interbody is a medical device manufactured by Ulrich Medical USA, Inc.. It received FDA 510(k) clearance on 2024-05-23 under approval number K241396. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the uCerv Flux™-C 3D Porous Titanium Cervical Interbody?

uCerv Flux™-C 3D Porous Titanium Cervical Interbody is a medical device that received FDA 510(k) clearance on 2024-05-23. It is manufactured by Ulrich Medical USA, Inc.. The 510(k) number is K241396.

When was uCerv Flux™-C 3D Porous Titanium Cervical Interbody approved by the FDA?

uCerv Flux™-C 3D Porous Titanium Cervical Interbody received FDA 510(k) clearance on 2024-05-23, under approval number K241396.

What company makes uCerv Flux™-C 3D Porous Titanium Cervical Interbody?

uCerv Flux™-C 3D Porous Titanium Cervical Interbody is manufactured by Ulrich Medical USA, Inc..

What is the FDA product code for uCerv Flux™-C 3D Porous Titanium Cervical Interbody?

The FDA product code for uCerv Flux™-C 3D Porous Titanium Cervical Interbody is ODP.

Related Clinical Trials

NCT04214535 Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Ulrich Medical USA, Inc.

K240515uNion® MAX Cervical Plate System K251719Momentum® Posterior Spinal Fixation System K252087Navigation Module of the Cortium® System

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑