FDA 510(k)

OMNI Anseris Hip Stem

K-Number: K171156 · 2017-08-17

Decision Date2017-08-17

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

OMNI Anseris Hip Stem is a medical device manufactured by Omnilife Science. It received FDA 510(k) clearance on 2017-08-17 under approval number K171156. 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 OMNI Anseris Hip Stem?

OMNI Anseris Hip Stem is a medical device that received FDA 510(k) clearance on 2017-08-17. It is manufactured by Omnilife Science. The 510(k) number is K171156.

When was OMNI Anseris Hip Stem approved by the FDA?

OMNI Anseris Hip Stem received FDA 510(k) clearance on 2017-08-17, under approval number K171156.

What company makes OMNI Anseris Hip Stem?

OMNI Anseris Hip Stem is manufactured by Omnilife Science.

What is the FDA product code for OMNI Anseris Hip Stem?

The FDA product code for OMNI Anseris Hip Stem is LZO.

Other Devices by Omnilife Science

K172467OMNI ARC Anteverted Neck Hip Stem K163332Apex Revision Knee System K201611Apex Knee System

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.