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FDA 510(k)

DISTAL RADIO-ULNAR JOINT IMPLANT

K-Number: K040497 · 2005-01-26

ApplicantAptis Medical, LLC
Decision Date2005-01-26
Product CodeKXE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DISTAL RADIO-ULNAR JOINT IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Aptis Medical, LLC. It received FDA 510(k) clearance on 2005-01-26 under 510(k) number K040497. 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 DISTAL RADIO-ULNAR JOINT IMPLANT?

DISTAL RADIO-ULNAR JOINT IMPLANT is a medical device that received FDA 510(k) clearance on 2005-01-26. The listed applicant is Aptis Medical, LLC. The 510(k) number is K040497.

When did DISTAL RADIO-ULNAR JOINT IMPLANT receive FDA 510(k) clearance?

DISTAL RADIO-ULNAR JOINT IMPLANT received FDA 510(k) clearance on 2005-01-26, under 510(k) number K040497.

Who is the listed applicant for DISTAL RADIO-ULNAR JOINT IMPLANT?

The FDA 510(k) record lists Aptis Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISTAL RADIO-ULNAR JOINT IMPLANT?

The FDA product code for DISTAL RADIO-ULNAR JOINT 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.

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Other records listing Aptis Medical, LLC 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.

K190599Aptis Medical Distal Radio Ulnar Joint ImplantK082839DISTAL RADIO-ULNAR JOINT IMPLANTK053119DISTAL RADIO-ULNAR JOINT IMPLANT

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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