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FDA 510(k)

Freedom Ultra-Congruent CR Tibial Liner

K-Number: K182574 · 2019-01-22

ApplicantMaxx Orthopedics, Inc.
Decision Date2019-01-22
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Freedom Ultra-Congruent CR Tibial Liner is a medical device manufactured by Maxx Orthopedics, Inc.. It received FDA 510(k) clearance on 2019-01-22 under approval number K182574. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Freedom Ultra-Congruent CR Tibial Liner?

Freedom Ultra-Congruent CR Tibial Liner is a medical device that received FDA 510(k) clearance on 2019-01-22. It is manufactured by Maxx Orthopedics, Inc.. The 510(k) number is K182574.

When was Freedom Ultra-Congruent CR Tibial Liner approved by the FDA?

Freedom Ultra-Congruent CR Tibial Liner received FDA 510(k) clearance on 2019-01-22, under approval number K182574.

What company makes Freedom Ultra-Congruent CR Tibial Liner?

Freedom Ultra-Congruent CR Tibial Liner is manufactured by Maxx Orthopedics, Inc..

What is the FDA product code for Freedom Ultra-Congruent CR Tibial Liner?

The FDA product code for Freedom Ultra-Congruent CR Tibial Liner is JWH.

Related Clinical Trials

NCT07544264 Evaluation of 5-year Survival and Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty With a Polyethylene Tibial Component NOT_YET_RECRUITING

Other Devices by Maxx Orthopedics, Inc.

K180973Libertas Hip Replacement System K192148Freedom Primary PCK K183684Libertas – Taper Uncemented Femoral Stem K183365Libertas Acetabular Hooded Liner K200912Freedom(R) - TiNbN Coated Knee K192989Libertas E-XLPE Modular Liner

View all 17 devices →

Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

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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