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FDA 510(k)

Opulent TiNbN Coated Knee

K-Number: K212839 · 2021-11-16

ApplicantMeril Healthcare Pvt. , Ltd.
Decision Date2021-11-16
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Opulent TiNbN Coated Knee is a medical device manufactured by Meril Healthcare Pvt. , Ltd.. It received FDA 510(k) clearance on 2021-11-16 under approval number K212839. 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 Opulent TiNbN Coated Knee?

Opulent TiNbN Coated Knee is a medical device that received FDA 510(k) clearance on 2021-11-16. It is manufactured by Meril Healthcare Pvt. , Ltd.. The 510(k) number is K212839.

When was Opulent TiNbN Coated Knee approved by the FDA?

Opulent TiNbN Coated Knee received FDA 510(k) clearance on 2021-11-16, under approval number K212839.

What company makes Opulent TiNbN Coated Knee?

Opulent TiNbN Coated Knee is manufactured by Meril Healthcare Pvt. , Ltd..

What is the FDA product code for Opulent TiNbN Coated Knee?

The FDA product code for Opulent TiNbN Coated Knee is JWH.

Other Devices by Meril Healthcare Pvt. , Ltd.

K172936Destiknee™ Total Knee System K172857Latitud Hip Replacement System K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws K183532Latitud Hip Replacement System K222816Opulent TiNbN Coated Knee K222436Latitud™ Hip Replacement System

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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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