FDA 510(k)

KLS Martin Individual Patient Solutions (IPS) Planning System

N.º K: K201052 · 2020-08-31

Fecha de decisión2020-08-31

Código de productoPPT

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

KLS Martin Individual Patient Solutions (IPS) Planning System is the device name listed in this FDA 510(k) record. The listed applicant is KLS-Martin L.P.. It received FDA 510(k) clearance on 2020-08-31 under 510(k) number K201052. The device is classified under product code PPT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the KLS Martin Individual Patient Solutions (IPS) Planning System?

KLS Martin Individual Patient Solutions (IPS) Planning System is a medical device that received FDA 510(k) clearance on 2020-08-31. The listed applicant is KLS-Martin L.P.. The 510(k) number is K201052.

When did KLS Martin Individual Patient Solutions (IPS) Planning System receive FDA 510(k) clearance?

KLS Martin Individual Patient Solutions (IPS) Planning System received FDA 510(k) clearance on 2020-08-31, under 510(k) number K201052.

Who is the listed applicant for KLS Martin Individual Patient Solutions (IPS) Planning System?

The FDA 510(k) record lists KLS-Martin L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KLS Martin Individual Patient Solutions (IPS) Planning System?

The FDA product code for KLS Martin Individual Patient Solutions (IPS) Planning System is PPT.

Ensayos clínicos relacionados

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Otros registros que enlistan a KLS-Martin L.P. como solicitante

K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions K253660KLS Martin Pure Pectus System K254162KLS Martin Ixos System K250988KLS Martin Pure Pectus System K250865KLS Martin IPS Forearm System K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

Ver todos los 33 dispositivos →

Dispositivos relacionados (Código: PPT)

K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic ModelsMaterialise NV K182889KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.K151285VSP Cranial System3D Systems, Inc.

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.