FDA 510(k)

Invictus Robotic Navigation Instruments

N.º K: K240951 · 2024-06-06

Fecha de decisión2024-06-06

Código de productoOLO

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Invictus Robotic Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine. It received FDA 510(k) clearance on 2024-06-06 under 510(k) number K240951. 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 Invictus Robotic Navigation Instruments?

Invictus Robotic Navigation Instruments is a medical device that received FDA 510(k) clearance on 2024-06-06. The listed applicant is Alphatec Spine. The 510(k) number is K240951.

When did Invictus Robotic Navigation Instruments receive FDA 510(k) clearance?

Invictus Robotic Navigation Instruments received FDA 510(k) clearance on 2024-06-06, under 510(k) number K240951.

Who is the listed applicant for Invictus Robotic Navigation Instruments?

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

What is the FDA product code for Invictus Robotic Navigation Instruments?

The FDA product code for Invictus Robotic Navigation Instruments is OLO.

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Otros registros que enlistan a Alphatec Spine como solicitante

K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System K191185Solanas® Posterior OCT Fixation System K160958Battalion Universal Spacer System

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

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.