FDA 510(k)

XLO Brand of Locking Distal Humerus Plating System

Numéro K : K233873 · 2024-04-26

DemandeurOrtho Life Systems Private Limited

Date de décision2024-04-26

Code produitHRS

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

XLO Brand of Locking Distal Humerus Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Life Systems Private Limited. It received FDA 510(k) clearance on 2024-04-26 under 510(k) number K233873. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the XLO Brand of Locking Distal Humerus Plating System?

XLO Brand of Locking Distal Humerus Plating System is a medical device that received FDA 510(k) clearance on 2024-04-26. The listed applicant is Ortho Life Systems Private Limited. The 510(k) number is K233873.

When did XLO Brand of Locking Distal Humerus Plating System receive FDA 510(k) clearance?

XLO Brand of Locking Distal Humerus Plating System received FDA 510(k) clearance on 2024-04-26, under 510(k) number K233873.

Who is the listed applicant for XLO Brand of Locking Distal Humerus Plating System?

The FDA 510(k) record lists Ortho Life Systems Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XLO Brand of Locking Distal Humerus Plating System?

The FDA product code for XLO Brand of Locking Distal Humerus Plating System is HRS.

Essais cliniques associés

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Dispositifs connexes (Code : HRS)

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Source officielle

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