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FDA 510(k)

Destiknee Total Knee System

K-Number: K160771 · 2016-12-19

ApplicantMeril Healthcare Private Limited
Decision Date2016-12-19
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Destiknee Total Knee System is a medical device manufactured by Meril Healthcare Private Limited. It received FDA 510(k) clearance on 2016-12-19 under approval number K160771. 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 2016-12-19. It is manufactured by Meril Healthcare Private Limited. The 510(k) number is K160771.

When was Destiknee Total Knee System approved by the FDA?

Destiknee Total Knee System received FDA 510(k) clearance on 2016-12-19, under approval number K160771.

What company makes Destiknee Total Knee System?

Destiknee Total Knee System is manufactured by Meril Healthcare Private Limited.

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. 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. K162222GENflex2 Total Knee SystemStelkast, Inc.

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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