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FDA 510(k)

KAPP CUSTOM ULNAR HEAD WRIST IMPLANT

K-Number: K033930 · 2004-07-28

ApplicantKapp Surgical Instrument, Inc.
Decision Date2004-07-28
Product CodeKXE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KAPP CUSTOM ULNAR HEAD WRIST 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 2004-07-28 under 510(k) number K033930. The device is classified under product code KXE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KAPP CUSTOM ULNAR HEAD WRIST IMPLANT?

KAPP CUSTOM ULNAR HEAD WRIST IMPLANT is a medical device that received FDA 510(k) clearance on 2004-07-28. The listed applicant is Kapp Surgical Instrument, Inc.. The 510(k) number is K033930.

When did KAPP CUSTOM ULNAR HEAD WRIST IMPLANT receive FDA 510(k) clearance?

KAPP CUSTOM ULNAR HEAD WRIST IMPLANT received FDA 510(k) clearance on 2004-07-28, under 510(k) number K033930.

Who is the listed applicant for KAPP CUSTOM ULNAR HEAD WRIST 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 ULNAR HEAD WRIST IMPLANT?

The FDA product code for KAPP CUSTOM ULNAR HEAD WRIST IMPLANT is KXE.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SYSTEMK030237KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT

View all 9 devices →

Related Devices (Code: KXE)

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.

K190599Aptis Medical Distal Radio Ulnar Joint ImplantAptis Medical, LLCK112481FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANTAscension OrthopedicK081025ISOELASTICURemi Sciences, Inc.K082839DISTAL RADIO-ULNAR JOINT IMPLANTAptis Medical, LLCK061146SBI ULNAR HEAD IMPLANTSmall Bone Innovations, Inc.K053119DISTAL RADIO-ULNAR JOINT IMPLANTAptis Medical, 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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