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FDA 510(k)

mBôs (Monogram mBôs TKA System)

K-Number: K242121 · 2025-03-14

ApplicantMonogram Orthopaedics, Inc.
Decision Date2025-03-14
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

mBôs (Monogram mBôs TKA System) is a medical device manufactured by Monogram Orthopaedics, Inc.. It received FDA 510(k) clearance on 2025-03-14 under approval number K242121. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the mBôs (Monogram mBôs TKA System)?

mBôs (Monogram mBôs TKA System) is a medical device that received FDA 510(k) clearance on 2025-03-14. It is manufactured by Monogram Orthopaedics, Inc.. The 510(k) number is K242121.

When was mBôs (Monogram mBôs TKA System) approved by the FDA?

mBôs (Monogram mBôs TKA System) received FDA 510(k) clearance on 2025-03-14, under approval number K242121.

What company makes mBôs (Monogram mBôs TKA System)?

mBôs (Monogram mBôs TKA System) is manufactured by Monogram Orthopaedics, Inc..

What is the FDA product code for mBôs (Monogram mBôs TKA System)?

The FDA product code for mBôs (Monogram mBôs TKA System) is OLO.

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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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