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FDA 510(k)

ANTHEM™ Fracture System

K-Number: K163361 · 2017-04-07

ApplicantGlobus Medical, Inc.
Decision Date2017-04-07
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 2017-04-07 under 510(k) number K163361. 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 2017-04-07. The listed applicant is Globus Medical, Inc.. The 510(k) number is K163361.

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

ANTHEM™ Fracture System received FDA 510(k) clearance on 2017-04-07, under 510(k) number K163361.

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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