FDA 510(k)

Libertas E-XLPE Modular Liner

K-Number: K192989 · 2020-10-29

Decision Date2020-10-29

Product CodeOQI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Libertas E-XLPE Modular Liner is a medical device manufactured by Maxx Orthopedics, Inc.. It received FDA 510(k) clearance on 2020-10-29 under approval number K192989. The device is classified under product code OQI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Libertas E-XLPE Modular Liner?

Libertas E-XLPE Modular Liner is a medical device that received FDA 510(k) clearance on 2020-10-29. It is manufactured by Maxx Orthopedics, Inc.. The 510(k) number is K192989.

When was Libertas E-XLPE Modular Liner approved by the FDA?

Libertas E-XLPE Modular Liner received FDA 510(k) clearance on 2020-10-29, under approval number K192989.

What company makes Libertas E-XLPE Modular Liner?

Libertas E-XLPE Modular Liner is manufactured by Maxx Orthopedics, Inc..

What is the FDA product code for Libertas E-XLPE Modular Liner?

The FDA product code for Libertas E-XLPE Modular Liner is OQI.

Other Devices by Maxx Orthopedics, Inc.

K180973Libertas Hip Replacement System K192148Freedom Primary PCK K183684Libertas Taper Uncemented Femoral Stem K183365Libertas Acetabular Hooded Liner K182574Freedom Ultra-Congruent CR Tibial Liner K200912Freedom(R) - TiNbN Coated Knee

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Related Devices (Code: OQI)

K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc. K252451EPORE® XO cup systemImplantcast GmbH

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.