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FDA 510(k)

Novae® Dual Mobility System, Hype® Hip System

K-Number: K223745 · 2023-12-22

ApplicantSerf
Decision Date2023-12-22
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Novae® Dual Mobility System, Hype® Hip System is a medical device manufactured by Serf. It received FDA 510(k) clearance on 2023-12-22 under approval number K223745. 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 Novae® Dual Mobility System, Hype® Hip System?

Novae® Dual Mobility System, Hype® Hip System is a medical device that received FDA 510(k) clearance on 2023-12-22. It is manufactured by Serf. The 510(k) number is K223745.

When was Novae® Dual Mobility System, Hype® Hip System approved by the FDA?

Novae® Dual Mobility System, Hype® Hip System received FDA 510(k) clearance on 2023-12-22, under approval number K223745.

What company makes Novae® Dual Mobility System, Hype® Hip System?

Novae® Dual Mobility System, Hype® Hip System is manufactured by Serf.

What is the FDA product code for Novae® Dual Mobility System, Hype® Hip System?

The FDA product code for Novae® Dual Mobility System, Hype® Hip System is LZO.

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Other Devices by Serf

K181744BI-MENTUM dual mobility 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

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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