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FDA 510(k)

Anthem Fracture System

K-Number: K212433 · 2021-10-01

ApplicantGlobus Medical, Inc.
Decision Date2021-10-01
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 2021-10-01 under approval number K212433. 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 2021-10-01. It is manufactured by Globus Medical, Inc.. The 510(k) number is K212433.

When was Anthem Fracture System approved by the FDA?

Anthem Fracture System received FDA 510(k) clearance on 2021-10-01, under approval number K212433.

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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