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FDA 510(k)

MT-Bone

K-Number: K242432 · 2024-08-19

Decision Date2024-08-19
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MT-Bone is the device name listed in this FDA 510(k) record. The listed applicant is Mectron S.P.A.. It received FDA 510(k) clearance on 2024-08-19 under 510(k) number K242432. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MT-Bone?

MT-Bone is a medical device that received FDA 510(k) clearance on 2024-08-19. The listed applicant is Mectron S.P.A.. The 510(k) number is K242432.

When did MT-Bone receive FDA 510(k) clearance?

MT-Bone received FDA 510(k) clearance on 2024-08-19, under 510(k) number K242432.

Who is the listed applicant for MT-Bone?

The FDA 510(k) record lists Mectron S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MT-Bone?

The FDA product code for MT-Bone is DZI.

Other records listing Mectron S.P.A. 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.

Related Devices (Code: DZI)

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.

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.