FDA 510(k)

ICONACY(TM) I-Hip (TM)

K-Number: K151307 · 2016-02-26

ApplicantIconacy Orthopedic Implants, LLC

Decision Date2016-02-26

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ICONACY(TM) I-Hip (TM) is a medical device manufactured by Iconacy Orthopedic Implants, LLC. It received FDA 510(k) clearance on 2016-02-26 under approval number K151307. 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 ICONACY(TM) I-Hip (TM)?

ICONACY(TM) I-Hip (TM) is a medical device that received FDA 510(k) clearance on 2016-02-26. It is manufactured by Iconacy Orthopedic Implants, LLC. The 510(k) number is K151307.

When was ICONACY(TM) I-Hip (TM) approved by the FDA?

ICONACY(TM) I-Hip (TM) received FDA 510(k) clearance on 2016-02-26, under approval number K151307.

What company makes ICONACY(TM) I-Hip (TM)?

ICONACY(TM) I-Hip (TM) is manufactured by Iconacy Orthopedic Implants, LLC.

What is the FDA product code for ICONACY(TM) I-Hip (TM)?

The FDA product code for ICONACY(TM) I-Hip (TM) is LZO.

Other Devices by Iconacy Orthopedic Implants, LLC

K160266ICONACY(TM) I-Hip(TM)

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

View on FDA Database →

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