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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 the device name listed in this FDA 510(k) record. The listed applicant is Serf. It received FDA 510(k) clearance on 2023-12-22 under 510(k) 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. The listed applicant is Serf. The 510(k) number is K223745.

When did Novae® Dual Mobility System, Hype® Hip System receive FDA 510(k) clearance?

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

Who is the listed applicant for Novae® Dual Mobility System, Hype® Hip System?

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

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.

Related Clinical Trials

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.

NCT04090359Dual Mobility Acetabular Cups in Revision TJARECRUITINGNCT04325022Safety and Effectiveness Study of OR3O™ Dual Mobility System in THAACTIVE_NOT_RECRUITINGNCT07207005Comparison of Wear Between Two Dual-mobility Acetabular Cups in Patients Undergoing Total Hip ArthroplastyRECRUITING

Other records listing Serf 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.

K181744BI-MENTUM dual mobility 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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