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FDA 510(k)

Integral Titanium Cervical Interbody

K-Number: K222015 · 2023-07-05

ApplicantNvision Biomedical Technologies, Inc.
Decision Date2023-07-05
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Integral Titanium Cervical Interbody is a medical device manufactured by Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2023-07-05 under approval number K222015. 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 Integral Titanium Cervical Interbody?

Integral Titanium Cervical Interbody is a medical device that received FDA 510(k) clearance on 2023-07-05. It is manufactured by Nvision Biomedical Technologies, Inc.. The 510(k) number is K222015.

When was Integral Titanium Cervical Interbody approved by the FDA?

Integral Titanium Cervical Interbody received FDA 510(k) clearance on 2023-07-05, under approval number K222015.

What company makes Integral Titanium Cervical Interbody?

Integral Titanium Cervical Interbody is manufactured by Nvision Biomedical Technologies, Inc..

What is the FDA product code for Integral Titanium Cervical Interbody?

The FDA product code for Integral 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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