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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 the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2019-01-17 under 510(k) 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. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K181338.

When did Imboki Knee Instrument System receive FDA 510(k) clearance?

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

Who is the listed applicant for Imboki Knee Instrument System?

The FDA 510(k) record lists Signature Orthopaedics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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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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