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FDA 510(k)

Imboki Knee Instrument System

K-Number: K181338 · 2019-01-17

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2019-01-17
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Imboki Knee Instrument System is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2019-01-17 under approval number K181338. 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 Imboki Knee Instrument System?

Imboki Knee Instrument System is a medical device that received FDA 510(k) clearance on 2019-01-17. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K181338.

When was Imboki Knee Instrument System approved by the FDA?

Imboki Knee Instrument System received FDA 510(k) clearance on 2019-01-17, under approval number K181338.

What company makes Imboki Knee Instrument System?

Imboki Knee Instrument System is manufactured by Signature Orthopaedics Pty, Ltd..

What is the FDA product code for Imboki Knee Instrument System?

The FDA product code for Imboki Knee Instrument System is JWH.

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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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