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FDA 510(k)

ERS RADIAL HEAD REPLACEMENT

K-Number: K000658 · 2000-05-11

ApplicantDePuy Orthopaedics, Inc.
Decision Date2000-05-11
Product CodeKWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ERS RADIAL HEAD REPLACEMENT is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2000-05-11 under 510(k) number K000658. 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 ERS RADIAL HEAD REPLACEMENT?

ERS RADIAL HEAD REPLACEMENT is a medical device that received FDA 510(k) clearance on 2000-05-11. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K000658.

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

ERS RADIAL HEAD REPLACEMENT received FDA 510(k) clearance on 2000-05-11, under 510(k) number K000658.

Who is the listed applicant for ERS RADIAL HEAD REPLACEMENT?

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

What is the FDA product code for ERS RADIAL HEAD REPLACEMENT?

The FDA product code for ERS RADIAL HEAD REPLACEMENT is KWI.

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Other records listing DePuy Orthopaedics, 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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