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FDA 510(k)

Coated hip implants

K-Number: K250450 · 2025-09-19

ApplicantMedacta International S.A.
Decision Date2025-09-19
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Coated hip implants is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K250450. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Coated hip implants?

Coated hip implants is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is Medacta International S.A.. The 510(k) number is K250450.

When did Coated hip implants receive FDA 510(k) clearance?

Coated hip implants received FDA 510(k) clearance on 2025-09-19, under 510(k) number K250450.

Who is the listed applicant for Coated hip implants?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Coated hip implants?

The FDA product code for Coated hip implants is LZO.

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.

NCT04251377Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint InfectionACTIVE_NOT_RECRUITING

Other records listing Medacta International S.A. 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.

K254202MectaLIF 3D Metal AnteriorK253940M.U.S.T. Pedicle Screw System - ExtensionK253328GMK 3D Metal Tibial Tray ExtensionK250644MSS - Monobloc stemK251043Mpact 3D Metal Implants Extension – DMLS TechnologyK252847NextAR Hip Platform

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Related Devices (Code: LZO)

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.

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbHK252401implaFit® short stemsImplantcast GmbHK253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.

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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