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FDA 510(k)

XLO Brand of Locking Distal Humerus Plating System

K-Number: K233873 · 2024-04-26

ApplicantOrtho Life Systems Private Limited
Decision Date2024-04-26
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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.

NCT07645768Is Anterior Reversed Proximal Humeral Locking Plate System (PHILOS) a Safe Alternative to Conventional Posterior Double Plating in Extra-Articular Distal Shaft Humeral FracturesACTIVE_NOT_RECRUITING

Related Devices (Code: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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