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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 the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2021-10-01 under 510(k) 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. The listed applicant is Globus Medical, Inc.. The 510(k) number is K212433.

When did Anthem Fracture System receive FDA 510(k) clearance?

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

Who is the listed applicant for Anthem Fracture System?

The FDA 510(k) record lists Globus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anthem Fracture System?

The FDA product code for Anthem Fracture 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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