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FDA 510(k)

RADIAL HEAD IMPLANT

K-Number: K982288 · 1998-09-08

ApplicantAvanta Orthopaedics, Inc.
Decision Date1998-09-08
Product CodeKWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RADIAL HEAD IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Avanta Orthopaedics, Inc.. It received FDA 510(k) clearance on 1998-09-08 under 510(k) number K982288. 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 RADIAL HEAD IMPLANT?

RADIAL HEAD IMPLANT is a medical device that received FDA 510(k) clearance on 1998-09-08. The listed applicant is Avanta Orthopaedics, Inc.. The 510(k) number is K982288.

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

RADIAL HEAD IMPLANT received FDA 510(k) clearance on 1998-09-08, under 510(k) number K982288.

Who is the listed applicant for RADIAL HEAD IMPLANT?

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

What is the FDA product code for RADIAL HEAD IMPLANT?

The FDA product code for RADIAL HEAD IMPLANT is KWI.

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Other records listing Avanta Orthopaedics, 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.

K030881AVANTA CARPAL FUSION PLATING SYSTEMK021859WRIST IMPLANTK023604MODIFICATION TO RADIAL HEAD IMPLANTK013629FINGER JOINT PROSTHESISK011819RADIAL HEAD IMPLANTK010847K'FIX

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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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