FDA 510(k)

CoreHip® System

K-Number: K172235 · 2018-03-28

Decision Date2018-03-28

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CoreHip® System is a medical device manufactured by Aesculap Implants Systems, LLC. It received FDA 510(k) clearance on 2018-03-28 under approval number K172235. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CoreHip® System?

CoreHip® System is a medical device that received FDA 510(k) clearance on 2018-03-28. It is manufactured by Aesculap Implants Systems, LLC. The 510(k) number is K172235.

When was CoreHip® System approved by the FDA?

CoreHip® System received FDA 510(k) clearance on 2018-03-28, under approval number K172235.

What company makes CoreHip® System?

CoreHip® System is manufactured by Aesculap Implants Systems, LLC.

What is the FDA product code for CoreHip® System?

The FDA product code for CoreHip® System is LZO.

Related Clinical Trials

NCT03685110 CoreHip - Post Market Clinical Follow-Up Study ACTIVE_NOT_RECRUITING

Other Devices by Aesculap Implants Systems, LLC

K231769activL® Next Generation Instrumentation

Related Devices (Code: LZO)

K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADKyocera Medical Corporation K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc. K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH K152893Corin Optimized Positioning System (OPS)Corin USA K160289MasterLoc StemMedacta International K152903REVIVAL(TM) Modular Revision Hip StemCorin USA

Official Source

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