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FDA 510(k)

Osteon Precision Milled Suprastructure

K-Number: K212676 · 2022-03-03

ApplicantImplant Solutions Pty Ltd (Osteon Medical)
Decision Date2022-03-03
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Osteon Precision Milled Suprastructure is the device name listed in this FDA 510(k) record. The listed applicant is Implant Solutions Pty Ltd (Osteon Medical). It received FDA 510(k) clearance on 2022-03-03 under 510(k) number K212676. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Osteon Precision Milled Suprastructure?

Osteon Precision Milled Suprastructure is a medical device that received FDA 510(k) clearance on 2022-03-03. The listed applicant is Implant Solutions Pty Ltd (Osteon Medical). The 510(k) number is K212676.

When did Osteon Precision Milled Suprastructure receive FDA 510(k) clearance?

Osteon Precision Milled Suprastructure received FDA 510(k) clearance on 2022-03-03, under 510(k) number K212676.

Who is the listed applicant for Osteon Precision Milled Suprastructure?

The FDA 510(k) record lists Implant Solutions Pty Ltd (Osteon Medical) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Osteon Precision Milled Suprastructure?

The FDA product code for Osteon Precision Milled Suprastructure is NHA.

Related Devices (Code: NHA)

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

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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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