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FDA 510(k)

Freedom(R) - TiNbN Coated Knee

K-Number: K200912 · 2020-11-18

ApplicantMaxx Orthopedics, Inc.
Decision Date2020-11-18
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Freedom(R) - TiNbN Coated Knee is a medical device manufactured by Maxx Orthopedics, Inc.. It received FDA 510(k) clearance on 2020-11-18 under approval number K200912. 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(R) - TiNbN Coated Knee?

Freedom(R) - TiNbN Coated Knee is a medical device that received FDA 510(k) clearance on 2020-11-18. It is manufactured by Maxx Orthopedics, Inc.. The 510(k) number is K200912.

When was Freedom(R) - TiNbN Coated Knee approved by the FDA?

Freedom(R) - TiNbN Coated Knee received FDA 510(k) clearance on 2020-11-18, under approval number K200912.

What company makes Freedom(R) - TiNbN Coated Knee?

Freedom(R) - TiNbN Coated Knee is manufactured by Maxx Orthopedics, Inc..

What is the FDA product code for Freedom(R) - TiNbN Coated Knee?

The FDA product code for Freedom(R) - TiNbN Coated Knee is JWH.

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Other Devices by Maxx Orthopedics, Inc.

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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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