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FDA 510(k)

Z1 Hip System

K-Number: K233476 · 2024-02-08

ApplicantOrchard Medical Development
Decision Date2024-02-08
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Z1 Hip System is a medical device manufactured by Orchard Medical Development. It received FDA 510(k) clearance on 2024-02-08 under approval number K233476. 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 Z1 Hip System?

Z1 Hip System is a medical device that received FDA 510(k) clearance on 2024-02-08. It is manufactured by Orchard Medical Development. The 510(k) number is K233476.

When was Z1 Hip System approved by the FDA?

Z1 Hip System received FDA 510(k) clearance on 2024-02-08, under approval number K233476.

What company makes Z1 Hip System?

Z1 Hip System is manufactured by Orchard Medical Development.

What is the FDA product code for Z1 Hip System?

The FDA product code for Z1 Hip System is LZO.

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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