FDA 510(k)

Invictus® Small Stature Spinal Fixation System

N.º K: K241519 · 2024-06-21

Fecha de decisión2024-06-21

Código de productoNKB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Invictus® Small Stature Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K241519. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Invictus® Small Stature Spinal Fixation System?

Invictus® Small Stature Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K241519.

When did Invictus® Small Stature Spinal Fixation System receive FDA 510(k) clearance?

Invictus® Small Stature Spinal Fixation System received FDA 510(k) clearance on 2024-06-21, under 510(k) number K241519.

Who is the listed applicant for Invictus® Small Stature Spinal Fixation System?

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

What is the FDA product code for Invictus® Small Stature Spinal Fixation System?

The FDA product code for Invictus® Small Stature Spinal Fixation System is NKB.

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Otros registros que enlistan a Alphatec Spine, Inc. como solicitante

K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System K253216IntraOp Alignment System; CONTOUR3D Bending System K253615Invictus Bands System K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)K252842SafeOp 3: Neural Informatix System K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)

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Dispositivos relacionados (Código: NKB)

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix Medical K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

Fuente oficial

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