FDA 510(k)

StealthStation S8 Spine Software

Número K: K251282 · 2025-10-17

Data da decisão2025-10-17

Código do produtoOLO

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

StealthStation S8 Spine Software is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K251282. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the StealthStation S8 Spine Software?

StealthStation S8 Spine Software is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K251282.

When did StealthStation S8 Spine Software receive FDA 510(k) clearance?

StealthStation S8 Spine Software received FDA 510(k) clearance on 2025-10-17, under 510(k) number K251282.

Who is the listed applicant for StealthStation S8 Spine Software?

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

What is the FDA product code for StealthStation S8 Spine Software?

The FDA product code for StealthStation S8 Spine Software is OLO.

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Outros registros que listam Medtronic Navigation, Inc. como candidato(a)

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Dispositivos Relacionados (Código: 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

Fonte oficial

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