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FDA 510(k)

Libertas Hip Replacement System

K-Number: K180973 · 2018-09-28

ApplicantMaxx Orthopedics, Inc.
Decision Date2018-09-28
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Libertas Hip Replacement System 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 2018-09-28 under 510(k) number K180973. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Libertas Hip Replacement System?

Libertas Hip Replacement System is a medical device that received FDA 510(k) clearance on 2018-09-28. The listed applicant is Maxx Orthopedics, Inc.. The 510(k) number is K180973.

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

Libertas Hip Replacement System received FDA 510(k) clearance on 2018-09-28, under 510(k) number K180973.

Who is the listed applicant for Libertas Hip Replacement System?

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 Hip Replacement System?

The FDA product code for Libertas Hip Replacement System is JDI.

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: JDI)

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.

K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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