FDA 510(k)

Stem Extension Line (USTAR II System)

K-Nummer: K252303 · 2025-08-22

AntragstellerUnited Orthopedic Corporation

Entscheidungsdatum2025-08-22

ProduktcodeKRO

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Stem Extension Line (USTAR II System) 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 2025-08-22 under 510(k) number K252303. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Stem Extension Line (USTAR II System)?

Stem Extension Line (USTAR II System) is a medical device that received FDA 510(k) clearance on 2025-08-22. The listed applicant is United Orthopedic Corporation. The 510(k) number is K252303.

When did Stem Extension Line (USTAR II System) receive FDA 510(k) clearance?

Stem Extension Line (USTAR II System) received FDA 510(k) clearance on 2025-08-22, under 510(k) number K252303.

Who is the listed applicant for Stem Extension Line (USTAR II System)?

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 Stem Extension Line (USTAR II System)?

The FDA product code for Stem Extension Line (USTAR II System) is KRO.

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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)K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella K242315Resolve Modular Revision Hip Stem K243466Conformity Stem Extension Line, #0 K243024Cellbrick Knee Spacer

Alle 27 Geräte anzeigen →

Verwandte Geräte (Code: KRO)

K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge BumperHowmedica Osteonics Corp., Dba Stryker Orthopaedics K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics K242871ATTUNE® Revision Hinterscharnier KnieDepuy Ireland UC K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial InseMicroport Orthopedics, Inc.K233980ATTUNE Total Kniegelenkssystem, ATTUNE cementfreies Kniegelenkssystem, LPS Gliederschonungssystem, Sigma Hochleistung (HP) Teil KniegelenkssystemDepuy Ireland UC

Offizielle Quelle

In der FDA-Datenbank anzeigen →

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