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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 a medical device manufactured by Implant Solutions Pty Ltd (Osteon Medical). It received FDA 510(k) clearance on 2022-03-03 under approval 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. It is manufactured by Implant Solutions Pty Ltd (Osteon Medical). The 510(k) number is K212676.

When was Osteon Precision Milled Suprastructure approved by the FDA?

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

What company makes Osteon Precision Milled Suprastructure?

Osteon Precision Milled Suprastructure is manufactured by Implant Solutions Pty Ltd (Osteon Medical).

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

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

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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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