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FDA 510(k)

Revolution Radial Head

K-Number: K183618 · 2019-05-17

ApplicantIgnite Orthopedics, Inc.
Decision Date2019-05-17
Product CodeKWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Revolution Radial Head is a medical device manufactured by Ignite Orthopedics, Inc.. It received FDA 510(k) clearance on 2019-05-17 under approval number K183618. The device is classified under product code KWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Revolution Radial Head?

Revolution Radial Head is a medical device that received FDA 510(k) clearance on 2019-05-17. It is manufactured by Ignite Orthopedics, Inc.. The 510(k) number is K183618.

When was Revolution Radial Head approved by the FDA?

Revolution Radial Head received FDA 510(k) clearance on 2019-05-17, under approval number K183618.

What company makes Revolution Radial Head?

Revolution Radial Head is manufactured by Ignite Orthopedics, Inc..

What is the FDA product code for Revolution Radial Head?

The FDA product code for Revolution Radial Head is KWI.

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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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