FDA 510(k)

Mpact 3D Metal Implants Extension – DMLS Technology

K-Nummer: K251043 · 2026-01-28

Entscheidungsdatum2026-01-28

ProduktcodeLPH

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Mpact 3D Metal Implants Extension – DMLS Technology 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 2026-01-28 under 510(k) number K251043. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Mpact 3D Metal Implants Extension – DMLS Technology?

Mpact 3D Metal Implants Extension – DMLS Technology is a medical device that received FDA 510(k) clearance on 2026-01-28. The listed applicant is Medacta International S.A.. The 510(k) number is K251043.

When did Mpact 3D Metal Implants Extension – DMLS Technology receive FDA 510(k) clearance?

Mpact 3D Metal Implants Extension – DMLS Technology received FDA 510(k) clearance on 2026-01-28, under 510(k) number K251043.

Who is the listed applicant for Mpact 3D Metal Implants Extension – DMLS Technology?

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 Mpact 3D Metal Implants Extension – DMLS Technology?

The FDA product code for Mpact 3D Metal Implants Extension – DMLS Technology is LPH.

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Weitere Einträge mit Medacta International S.A. als Antragsteller

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K261453G7® Acetabular SystemZimmer Biomet K253630Mpact 3D Metal FoamMedacta International S.A.K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC K251270Taperloc® Complete Hip StemBiomet, Inc.

Offizielle Quelle

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