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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 the device name listed in this FDA 510(k) record. The listed applicant is Meril Healthcare Private Limited. It received FDA 510(k) clearance on 2016-12-19 under 510(k) 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. The listed applicant is Meril Healthcare Private Limited. The 510(k) number is K160771.

When did Destiknee Total Knee System receive FDA 510(k) clearance?

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

Who is the listed applicant for Destiknee Total Knee System?

The FDA 510(k) record lists Meril Healthcare Private Limited as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: JWH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NVK252974EMPOWR KneeEncore 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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