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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 the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2023-07-05 under 510(k) 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. The listed applicant is Nvision Biomedical Technologies, Inc.. The 510(k) number is K222015.

When did Integral Titanium Cervical Interbody receive FDA 510(k) clearance?

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

Who is the listed applicant for Integral Titanium Cervical Interbody?

The FDA 510(k) record lists Nvision Biomedical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Integral Titanium Cervical Interbody is ODP.

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Related Devices (Code: ODP)

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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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