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FDA 510(k)

EVOLVE CERAMIC RADIAL HEAD IMPLANT

K-Number: K030384 · 2003-08-12

ApplicantWrightmedicaltechnologyinc
Decision Date2003-08-12
Product CodeKWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EVOLVE CERAMIC RADIAL HEAD IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2003-08-12 under 510(k) number K030384. 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 EVOLVE CERAMIC RADIAL HEAD IMPLANT?

EVOLVE CERAMIC RADIAL HEAD IMPLANT is a medical device that received FDA 510(k) clearance on 2003-08-12. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K030384.

When did EVOLVE CERAMIC RADIAL HEAD IMPLANT receive FDA 510(k) clearance?

EVOLVE CERAMIC RADIAL HEAD IMPLANT received FDA 510(k) clearance on 2003-08-12, under 510(k) number K030384.

Who is the listed applicant for EVOLVE CERAMIC RADIAL HEAD IMPLANT?

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

What is the FDA product code for EVOLVE CERAMIC RADIAL HEAD IMPLANT?

The FDA product code for EVOLVE CERAMIC RADIAL HEAD IMPLANT is KWI.

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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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