FDA 510(k)

kneeEOS

K-Number: K161828 · 2016-10-03

Decision Date2016-10-03

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

kneeEOS is the device name listed in this FDA 510(k) record. The listed applicant is Onefit Medical. It received FDA 510(k) clearance on 2016-10-03 under 510(k) number K161828. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the kneeEOS?

kneeEOS is a medical device that received FDA 510(k) clearance on 2016-10-03. The listed applicant is Onefit Medical. The 510(k) number is K161828.

When did kneeEOS receive FDA 510(k) clearance?

kneeEOS received FDA 510(k) clearance on 2016-10-03, under 510(k) number K161828.

Who is the listed applicant for kneeEOS?

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

What is the FDA product code for kneeEOS?

The FDA product code for kneeEOS is LLZ.

Other records listing Onefit Medical 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.

K173390hipEOS K161479hipEOS K160407spineEOS

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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.