FDA 510(k)

Sistema de Instrumentos de Navegación ASTRA & AVANT y Sistema de Instrumentos de Navegación ASTRA-OCT

N.º K: K223301 · 2023-07-20

Fecha de decisión2023-07-20

Código de productoOLO

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System is the device name listed in this FDA 510(k) record. The listed applicant is Spinecraft, LLC. It received FDA 510(k) clearance on 2023-07-20 under 510(k) number K223301. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System?

ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System is a medical device that received FDA 510(k) clearance on 2023-07-20. The listed applicant is Spinecraft, LLC. The 510(k) number is K223301.

When did ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System receive FDA 510(k) clearance?

ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System received FDA 510(k) clearance on 2023-07-20, under 510(k) number K223301.

Who is the listed applicant for ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System?

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

What is the FDA product code for ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System?

The FDA product code for ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System is OLO.

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Otros registros que enlistan a Spinecraft, LLC como solicitante

K223273Sistema de Espina ASTRA K211935ORIO-Ti Intervertebral Body Fusion Cage System K211323Sistema de Espina ASTRA K181350Sistema ASTRA-OCT Espina

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

Fuente oficial

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