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FDA 510(k)

KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT

K-Number: K030237 · 2003-08-29

ApplicantKapp Surgical Instrument, Inc.
Decision Date2003-08-29
Product CodeKWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Kapp Surgical Instrument, Inc.. It received FDA 510(k) clearance on 2003-08-29 under 510(k) number K030237. 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 KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT?

KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT is a medical device that received FDA 510(k) clearance on 2003-08-29. The listed applicant is Kapp Surgical Instrument, Inc.. The 510(k) number is K030237.

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

KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT received FDA 510(k) clearance on 2003-08-29, under 510(k) number K030237.

Who is the listed applicant for KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT?

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

What is the FDA product code for KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT?

The FDA product code for KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT is KWI.

Related Clinical Trials

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.

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Other records listing Kapp Surgical Instrument, 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.

K200289Michler-Kapp Cardiovascular Vent CatheterK072216KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536K050384KAPP BARI-RING, MODEL KS-BR-2005K050655MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005K050657MONDEAL CONTOUR HO SYSTEMK033930KAPP CUSTOM ULNAR HEAD WRIST IMPLANT

View all 9 devices →

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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