Osteon Precision Milled Suprastructure
K-Number: K233083 · 2024-03-09
Decision Date2024-03-09
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Osteon Precision Milled Suprastructure is a medical device manufactured by Implant Solutions Pty Ltd (Aka Osteon Medical). It received FDA 510(k) clearance on 2024-03-09 under approval number K233083. 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 2024-03-09. It is manufactured by Implant Solutions Pty Ltd (Aka Osteon Medical). The 510(k) number is K233083.
When was Osteon Precision Milled Suprastructure approved by the FDA?
Osteon Precision Milled Suprastructure received FDA 510(k) clearance on 2024-03-09, under approval number K233083.
What company makes Osteon Precision Milled Suprastructure?
Osteon Precision Milled Suprastructure is manufactured by Implant Solutions Pty Ltd (Aka Osteon Medical).
What is the FDA product code for Osteon Precision Milled Suprastructure?
The FDA product code for Osteon Precision Milled Suprastructure is NHA.
Other Devices by Implant Solutions Pty Ltd (Aka Osteon Medical)
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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.