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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 the device name listed in this FDA 510(k) record. The listed applicant is Orchard Medical Development. It received FDA 510(k) clearance on 2024-02-08 under 510(k) 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. The listed applicant is Orchard Medical Development. The 510(k) number is K233476.

When did Z1 Hip System receive FDA 510(k) clearance?

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

Who is the listed applicant for Z1 Hip System?

The FDA 510(k) record lists Orchard Medical Development as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Z1 Hip System?

The FDA product code for Z1 Hip System is LZO.

Other records listing Orchard Medical Development as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241241Z1 Cemented Hip System

Related Devices (Code: LZO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbHK252401implaFit® short stemsImplantcast GmbHK253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.

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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