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FDA 510(k)

HERBERT ULNAR HEAD PROSTHESIS SYSTEM

K-Number: K042902 · 2004-12-27

ApplicantStuckenbrock Medizintechnik GmbH
Decision Date2004-12-27
Product CodeKXE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HERBERT ULNAR HEAD PROSTHESIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stuckenbrock Medizintechnik GmbH. It received FDA 510(k) clearance on 2004-12-27 under 510(k) number K042902. 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 HERBERT ULNAR HEAD PROSTHESIS SYSTEM?

HERBERT ULNAR HEAD PROSTHESIS SYSTEM is a medical device that received FDA 510(k) clearance on 2004-12-27. The listed applicant is Stuckenbrock Medizintechnik GmbH. The 510(k) number is K042902.

When did HERBERT ULNAR HEAD PROSTHESIS SYSTEM receive FDA 510(k) clearance?

HERBERT ULNAR HEAD PROSTHESIS SYSTEM received FDA 510(k) clearance on 2004-12-27, under 510(k) number K042902.

Who is the listed applicant for HERBERT ULNAR HEAD PROSTHESIS SYSTEM?

The FDA 510(k) record lists Stuckenbrock Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HERBERT ULNAR HEAD PROSTHESIS SYSTEM?

The FDA product code for HERBERT ULNAR HEAD PROSTHESIS SYSTEM is KXE.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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