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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 the device name listed in this FDA 510(k) record. The listed applicant is Ulrich Medical USA, Inc.. It received FDA 510(k) clearance on 2024-05-23 under 510(k) 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. The listed applicant is Ulrich Medical USA, Inc.. The 510(k) number is K241396.

When did uCerv Flux™-C 3D Porous Titanium Cervical Interbody receive FDA 510(k) clearance?

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

Who is the listed applicant for uCerv Flux™-C 3D Porous Titanium Cervical Interbody?

The FDA 510(k) record lists Ulrich Medical USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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NCT05583864Lumbar Fusion With Porous Versus Non-Porous CagesACTIVE_NOT_RECRUITING

Other records listing Ulrich Medical USA, Inc. as applicant

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Related Devices (Code: ODP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.

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.

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