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FDA 510(k)

MODULAR RADIAL HEAD REPLACEMENT DEVICE

K-Number: K040611 · 2004-06-04

ApplicantBiomet, Inc.
Decision Date2004-06-04
Product CodeKWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODULAR RADIAL HEAD REPLACEMENT DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2004-06-04 under 510(k) number K040611. 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 MODULAR RADIAL HEAD REPLACEMENT DEVICE?

MODULAR RADIAL HEAD REPLACEMENT DEVICE is a medical device that received FDA 510(k) clearance on 2004-06-04. The listed applicant is Biomet, Inc.. The 510(k) number is K040611.

When did MODULAR RADIAL HEAD REPLACEMENT DEVICE receive FDA 510(k) clearance?

MODULAR RADIAL HEAD REPLACEMENT DEVICE received FDA 510(k) clearance on 2004-06-04, under 510(k) number K040611.

Who is the listed applicant for MODULAR RADIAL HEAD REPLACEMENT DEVICE?

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

What is the FDA product code for MODULAR RADIAL HEAD REPLACEMENT DEVICE?

The FDA product code for MODULAR RADIAL HEAD REPLACEMENT DEVICE is KWI.

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Other records listing Biomet, Inc. as applicant

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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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