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FDA 510(k)

ELEOS Limb Salvage System

K-Number: K161520 · 2016-10-28

ApplicantOnkos Surgical, Inc.
Decision Date2016-10-28
Product CodeKRO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ELEOS Limb Salvage System is the device name listed in this FDA 510(k) record. The listed applicant is Onkos Surgical, Inc.. It received FDA 510(k) clearance on 2016-10-28 under 510(k) number K161520. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELEOS Limb Salvage System?

ELEOS Limb Salvage System is a medical device that received FDA 510(k) clearance on 2016-10-28. The listed applicant is Onkos Surgical, Inc.. The 510(k) number is K161520.

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

ELEOS Limb Salvage System received FDA 510(k) clearance on 2016-10-28, under 510(k) number K161520.

Who is the listed applicant for ELEOS Limb Salvage System?

The FDA 510(k) record lists Onkos Surgical, Inc. 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.

Other records listing Onkos Surgical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253066ELEOS™ with NanoCept® Technology Limb Salvage SystemK252920ELEOS™ Limb Salvage System with NanoCept® TechnologyK223348My3D® Personalized Pelvic ReconstructionK212815My3D® Personalized Pelvic ReconstructionK211677ELEOS Limb Salvage SystemK203815ELEOS Limb Salvage System with BioGrip

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Related Devices (Code: KRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 OrthopaedicsK252303Stem Extension Line (USTAR II System)United Orthopedic CorporationK251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK242871ATTUNE™ Revision Hinge KneeDepuy Ireland UCK240043EVOLUTION® 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.K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee SystemDepuy Ireland UC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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