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FDA 510(k)

ANTHEM® Fracture System

K-Number: K251161 · 2025-08-18

ApplicantGlobus Medical, Inc.
Decision Date2025-08-18
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANTHEM® Fracture System is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2025-08-18 under approval number K251161. 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 ANTHEM® Fracture System?

ANTHEM® Fracture System is a medical device that received FDA 510(k) clearance on 2025-08-18. It is manufactured by Globus Medical, Inc.. The 510(k) number is K251161.

When was ANTHEM® Fracture System approved by the FDA?

ANTHEM® Fracture System received FDA 510(k) clearance on 2025-08-18, under approval number K251161.

What company makes ANTHEM® Fracture System?

ANTHEM® Fracture System is manufactured by Globus Medical, Inc..

What is the FDA product code for ANTHEM® Fracture System?

The FDA product code for ANTHEM® Fracture System is HRS.

Related Clinical Trials

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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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