FDA 510(k)

ELEOS Limb Salvage System

N.º K: K211677 · 2021-07-28

Fecha de decisión2021-07-28

Código de productoKRO

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

ELEOS Limb Salvage System is the device name listed in this FDA 510(k) record. The listed applicant is Onkos Surgical. It received FDA 510(k) clearance on 2021-07-28 under 510(k) number K211677. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ELEOS Limb Salvage System?

ELEOS Limb Salvage System is a medical device that received FDA 510(k) clearance on 2021-07-28. The listed applicant is Onkos Surgical. The 510(k) number is K211677.

When did ELEOS Limb Salvage System receive FDA 510(k) clearance?

ELEOS Limb Salvage System received FDA 510(k) clearance on 2021-07-28, under 510(k) number K211677.

Who is the listed applicant for ELEOS Limb Salvage System?

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

What is the FDA product code for ELEOS Limb Salvage System?

The FDA product code for ELEOS Limb Salvage System is KRO.

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Otros registros que enlistan a Onkos Surgical como solicitante

K212815My3D® Personalized Pelvic Reconstruction K203815ELEOS Limb Salvage System with BioGrip K203588ELEOS™ Limb Salvage System K203090ELEOS Limb Salvage System featuring BIOGRIP

Dispositivos relacionados (Código: KRO)

K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge BumperHowmedica Osteonics Corp., Dba Stryker Orthopaedics K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics K242871Rodilla de Bisagra Revision ATTUNE™Depuy Ireland UC K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial InseMicroport Orthopedics, Inc.

Fuente oficial

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