FDA 510(k)

United U2 femoral head, 22mm delta ceramic head

K-Nummer: K221675 · 2022-11-04

AntragstellerUnited Orthopedic Corporation

Entscheidungsdatum2022-11-04

ProduktcodeLPH

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

United U2 femoral head, 22mm delta ceramic head is the device name listed in this FDA 510(k) record. The listed applicant is United Orthopedic Corporation. It received FDA 510(k) clearance on 2022-11-04 under 510(k) number K221675. 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 United U2 femoral head, 22mm delta ceramic head?

United U2 femoral head, 22mm delta ceramic head is a medical device that received FDA 510(k) clearance on 2022-11-04. The listed applicant is United Orthopedic Corporation. The 510(k) number is K221675.

When did United U2 femoral head, 22mm delta ceramic head receive FDA 510(k) clearance?

United U2 femoral head, 22mm delta ceramic head received FDA 510(k) clearance on 2022-11-04, under 510(k) number K221675.

Who is the listed applicant for United U2 femoral head, 22mm delta ceramic head?

The FDA 510(k) record lists United Orthopedic Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for United U2 femoral head, 22mm delta ceramic head?

The FDA product code for United U2 femoral head, 22mm delta ceramic head is LPH.

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Weitere Einträge mit United Orthopedic Corporation als Antragsteller

K253948Momentum Acetabular Cup System K252725Stem Extension Line (U2 Total Knee System—PSA Type)K252303Stem Extension Line (USTAR II System)K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella K242315Resolve Modular Revision Hip Stem K243466Conformity Stem Extension Line, #0

Alle 27 Geräte anzeigen →

Verwandte Geräte (Code: LPH)

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

In der FDA-Datenbank anzeigen →

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