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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 the device name listed in this FDA 510(k) record. The listed applicant is Monogram Orthopaedics, Inc.. It received FDA 510(k) clearance on 2025-03-14 under 510(k) 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. The listed applicant is Monogram Orthopaedics, Inc.. The 510(k) number is K242121.

When did mBôs (Monogram mBôs TKA System) receive FDA 510(k) clearance?

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

Who is the listed applicant for mBôs (Monogram mBôs TKA System)?

The FDA 510(k) record lists Monogram Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: OLO)

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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