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FDA 510(k)

ELEOS™ Bipolar Acetabular System

K-Number: K180130 · 2018-02-23

ApplicantOnkos Surgical, Inc.
Decision Date2018-02-23
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ELEOS™ Bipolar Acetabular 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 2018-02-23 under 510(k) number K180130. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELEOS™ Bipolar Acetabular System?

ELEOS™ Bipolar Acetabular System is a medical device that received FDA 510(k) clearance on 2018-02-23. The listed applicant is Onkos Surgical, Inc.. The 510(k) number is K180130.

When did ELEOS™ Bipolar Acetabular System receive FDA 510(k) clearance?

ELEOS™ Bipolar Acetabular System received FDA 510(k) clearance on 2018-02-23, under 510(k) number K180130.

Who is the listed applicant for ELEOS™ Bipolar Acetabular 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™ Bipolar Acetabular System?

The FDA product code for ELEOS™ Bipolar Acetabular System is KWY.

Other records listing Onkos Surgical, Inc. as applicant

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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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