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FDA 510(k)

Bonafix 2 Plus

K-Number: K213677 · 2022-12-20

ApplicantZentek Medical, LLC
Decision Date2022-12-20
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Bonafix 2 Plus is the device name listed in this FDA 510(k) record. The listed applicant is Zentek Medical, LLC. It received FDA 510(k) clearance on 2022-12-20 under 510(k) number K213677. 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 Bonafix 2 Plus?

Bonafix 2 Plus is a medical device that received FDA 510(k) clearance on 2022-12-20. The listed applicant is Zentek Medical, LLC. The 510(k) number is K213677.

When did Bonafix 2 Plus receive FDA 510(k) clearance?

Bonafix 2 Plus received FDA 510(k) clearance on 2022-12-20, under 510(k) number K213677.

Who is the listed applicant for Bonafix 2 Plus?

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

What is the FDA product code for Bonafix 2 Plus?

The FDA product code for Bonafix 2 Plus is DZE.

Other records listing Zentek Medical, LLC as applicant

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.

K251294Bonafix Implant AbutmentsK221673Bonafix TiBase

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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