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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 the device name listed in this FDA 510(k) record. The listed applicant is Ignite Orthopedics, Inc.. It received FDA 510(k) clearance on 2019-05-17 under 510(k) 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. The listed applicant is Ignite Orthopedics, Inc.. The 510(k) number is K183618.

When did Revolution Radial Head receive FDA 510(k) clearance?

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

Who is the listed applicant for Revolution Radial Head?

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

What is the FDA product code for Revolution Radial Head?

The FDA product code for Revolution Radial Head is KWI.

Other records listing Ignite Orthopedics, Inc. 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.

K203108Ignite Stemless Anatomic Shoulder SystemK202716Ignite Anatomic Shoulder System

Related Devices (Code: KWI)

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.

K260624Arthrex Radial Head Replacement SystemArthrex, Inc.K233592BioPoly Radial Head ImplantBioPoly, LLCK231188ALIGN Radial Head SystemSkeletal Dynamics, Inc.K213563DePuy Synthes Radial Head Replacement SystemDePuy SynthesK212872Avenger Radial Head SystemIn2bones USA, LLCK192754Avenger Radial Head SystemIn2bones USA, LLC

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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