FDA 510(k)

OsteoCentric Navigated Instruments System

Номер K: K250520 · 2025-10-27

ЗаявительOsteocentric Technologies, Inc.

Дата решения2025-10-27

Код продуктаOLO

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

OsteoCentric Navigated Instruments System is the device name listed in this FDA 510(k) record. The listed applicant is Osteocentric Technologies, Inc.. It received FDA 510(k) clearance on 2025-10-27 under 510(k) number K250520. 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 OsteoCentric Navigated Instruments System?

OsteoCentric Navigated Instruments System is a medical device that received FDA 510(k) clearance on 2025-10-27. The listed applicant is Osteocentric Technologies, Inc.. The 510(k) number is K250520.

When did OsteoCentric Navigated Instruments System receive FDA 510(k) clearance?

OsteoCentric Navigated Instruments System received FDA 510(k) clearance on 2025-10-27, under 510(k) number K250520.

Who is the listed applicant for OsteoCentric Navigated Instruments System?

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

What is the FDA product code for OsteoCentric Navigated Instruments System?

The FDA product code for OsteoCentric Navigated Instruments 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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