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FDA 510(k)

Libertas Acetabular Hooded Liner

K-Number: K183365 · 2019-02-22

ApplicantMaxx Orthopedics, Inc.
Decision Date2019-02-22
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Libertas Acetabular Hooded Liner is the device name listed in this FDA 510(k) record. The listed applicant is Maxx Orthopedics, Inc.. It received FDA 510(k) clearance on 2019-02-22 under 510(k) number K183365. 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 Libertas Acetabular Hooded Liner?

Libertas Acetabular Hooded Liner is a medical device that received FDA 510(k) clearance on 2019-02-22. The listed applicant is Maxx Orthopedics, Inc.. The 510(k) number is K183365.

When did Libertas Acetabular Hooded Liner receive FDA 510(k) clearance?

Libertas Acetabular Hooded Liner received FDA 510(k) clearance on 2019-02-22, under 510(k) number K183365.

Who is the listed applicant for Libertas Acetabular Hooded Liner?

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

What is the FDA product code for Libertas Acetabular Hooded Liner?

The FDA product code for Libertas Acetabular Hooded Liner 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.

NCT06627673MultiCenter IDE Study of the PEEK-OPTIMA™ Femoral Component vs a CoCr Alloy TKA Femoral Component of Similar DesignRECRUITINGNCT06627699Prospective, In-Vivo, Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics, Freedom Total Knee® SystemRECRUITING

Other records listing Maxx Orthopedics, Inc. 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.

K261563Freedom Total Knee System (E-Poly Tibial Liners)K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)K253314Freedom Infinia™ Total Knee SystemK253144Freedom® Total Knee System – Titan PCK ComponentsK243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)

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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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