FDA 510(k)

OsteoCentric Navigated Instruments System

Número K: K250520 · 2025-10-27

RequerenteOsteocentric Technologies, Inc.

Data da decisão2025-10-27

Código do produtoOLO

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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