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FDA 510(k)

OMNIBotics Knee System

K-Number: K163338 · 2017-09-01

ApplicantOmnllife Science, Inc.
Decision Date2017-09-01
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OMNIBotics Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Omnllife Science, Inc.. It received FDA 510(k) clearance on 2017-09-01 under 510(k) number K163338. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNIBotics Knee System?

OMNIBotics Knee System is a medical device that received FDA 510(k) clearance on 2017-09-01. The listed applicant is Omnllife Science, Inc.. The 510(k) number is K163338.

When did OMNIBotics Knee System receive FDA 510(k) clearance?

OMNIBotics Knee System received FDA 510(k) clearance on 2017-09-01, under 510(k) number K163338.

Who is the listed applicant for OMNIBotics Knee System?

The FDA 510(k) record lists Omnllife Science, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMNIBotics Knee System?

The FDA product code for OMNIBotics Knee System is OLO.

Related Devices (Code: OLO)

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.

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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.

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