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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 a medical device manufactured by Ortho Life Systems Private Limited. It received FDA 510(k) clearance on 2024-04-26 under approval 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. It is manufactured by Ortho Life Systems Private Limited. The 510(k) number is K233873.

When was XLO Brand of Locking Distal Humerus Plating System approved by the FDA?

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

What company makes XLO Brand of Locking Distal Humerus Plating System?

XLO Brand of Locking Distal Humerus Plating System is manufactured by Ortho Life Systems Private Limited.

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.

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Official Source

View on FDA Database →

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

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