FDA 510(k)

Pytheas Your Guided Trajectory

Номер K: K252880 · 2026-05-11

Дата решения2026-05-11

Код продуктаOLO

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

Pytheas Your Guided Trajectory is the device name listed in this FDA 510(k) record. The listed applicant is Pytheas Navigation Sas. It received FDA 510(k) clearance on 2026-05-11 under 510(k) number K252880. 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 Pytheas Your Guided Trajectory?

Pytheas Your Guided Trajectory is a medical device that received FDA 510(k) clearance on 2026-05-11. The listed applicant is Pytheas Navigation Sas. The 510(k) number is K252880.

When did Pytheas Your Guided Trajectory receive FDA 510(k) clearance?

Pytheas Your Guided Trajectory received FDA 510(k) clearance on 2026-05-11, under 510(k) number K252880.

Who is the listed applicant for Pytheas Your Guided Trajectory?

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

What is the FDA product code for Pytheas Your Guided Trajectory?

The FDA product code for Pytheas Your Guided Trajectory 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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