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FDA 510(k)

EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE

K-Number: K051385 · 2005-08-05

ApplicantBiomet, Inc.
Decision Date2005-08-05
Product CodeKWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXPLOR 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 2005-08-05 under 510(k) number K051385. 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 EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE?

EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE is a medical device that received FDA 510(k) clearance on 2005-08-05. The listed applicant is Biomet, Inc.. The 510(k) number is K051385.

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

EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE received FDA 510(k) clearance on 2005-08-05, under 510(k) number K051385.

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

The FDA product code for EXPLOR 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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