FDA 510(k)

mBôs (Monogram mBôs TKA System)

Номер K: K242121 · 2025-03-14

Дата решения2025-03-14

Код продуктаOLO

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: OLO)

K262506Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp.K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation Centre K261205SPINEART Navigation Instrument SystemSpineart SA K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K262121Ion-L Navigated InstrumentsSurGenTec, LLC K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics

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