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FDA 510(k)

uCerv Flux-C 3D Porous Titanium Cervical Interbody

K-Number: K220696 · 2022-08-19

ApplicantUlrich Medical USA
Decision Date2022-08-19
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. It received FDA 510(k) clearance on 2022-08-19 under approval number K220696. 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 2022-08-19. It is manufactured by Ulrich Medical USA. The 510(k) number is K220696.

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 2022-08-19, under approval number K220696.

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.

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)

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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.

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