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FDA 510(k)

TSX Implants

K-Number: K220978 · 2022-09-14

ApplicantBiomet 3i, LLC
Decision Date2022-09-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TSX Implants is the device name listed in this FDA 510(k) record. The listed applicant is Biomet 3i, LLC. It received FDA 510(k) clearance on 2022-09-14 under 510(k) number K220978. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TSX Implants?

TSX Implants is a medical device that received FDA 510(k) clearance on 2022-09-14. The listed applicant is Biomet 3i, LLC. The 510(k) number is K220978.

When did TSX Implants receive FDA 510(k) clearance?

TSX Implants received FDA 510(k) clearance on 2022-09-14, under 510(k) number K220978.

Who is the listed applicant for TSX Implants?

The FDA 510(k) record lists Biomet 3i, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TSX Implants?

The FDA product code for TSX Implants is DZE.

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Related Devices (Code: DZE)

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.

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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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