FDA 510(k)

Invictus® Bone Cement, Invictus Spinal Fixation System

N.º K: K221926 · 2022-12-20

Fecha de decisión2022-12-20

Código de productoPML

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Invictus® Bone Cement, Invictus 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 2022-12-20 under 510(k) number K221926. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Invictus® Bone Cement, Invictus Spinal Fixation System?

Invictus® Bone Cement, Invictus Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2022-12-20. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K221926.

When did Invictus® Bone Cement, Invictus Spinal Fixation System receive FDA 510(k) clearance?

Invictus® Bone Cement, Invictus Spinal Fixation System received FDA 510(k) clearance on 2022-12-20, under 510(k) number K221926.

Who is the listed applicant for Invictus® Bone Cement, Invictus 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® Bone Cement, Invictus Spinal Fixation System?

The FDA product code for Invictus® Bone Cement, Invictus Spinal Fixation System is PML.

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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: PML)

K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone CementUlrich Medical USA K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart K222789VADER® Pedicle System, G21 CementIcotec AG

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.