FDA 510(k)

ELEOS Bipolar Acetabular System

K-Number: K180130 · 2018-02-23

Decision Date2018-02-23

Product CodeKWY

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ELEOS Bipolar Acetabular System is a medical device manufactured by Onkos Surgical, Inc.. It received FDA 510(k) clearance on 2018-02-23 under approval 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. It is manufactured by Onkos Surgical, Inc.. The 510(k) number is K180130.

When was ELEOS Bipolar Acetabular System approved by the FDA?

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

What company makes ELEOS Bipolar Acetabular System?

ELEOS Bipolar Acetabular System is manufactured by Onkos Surgical, Inc..

What is the FDA product code for ELEOS Bipolar Acetabular System?

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

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Official Source

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