FDA 510(k)

Destiknee Total Knee System

K-Number: K172936 · 2017-11-30

Decision Date2017-11-30

Product CodeJWH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Destiknee Total Knee System is a medical device manufactured by Meril Healthcare Pvt. , Ltd.. It received FDA 510(k) clearance on 2017-11-30 under approval number K172936. 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 Destiknee Total Knee System?

Destiknee Total Knee System is a medical device that received FDA 510(k) clearance on 2017-11-30. It is manufactured by Meril Healthcare Pvt. , Ltd.. The 510(k) number is K172936.

When was Destiknee Total Knee System approved by the FDA?

Destiknee Total Knee System received FDA 510(k) clearance on 2017-11-30, under approval number K172936.

What company makes Destiknee Total Knee System?

Destiknee Total Knee System is manufactured by Meril Healthcare Pvt. , Ltd..

What is the FDA product code for Destiknee Total Knee System?

The FDA product code for Destiknee Total Knee System is JWH.

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Related PubMed Literature

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Other Devices by Meril Healthcare Pvt. , Ltd.

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 K212839Opulent TiNbN Coated Knee 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.