Imboki Knee Instrument System

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

Signature Orthopaedics Pty Ltd.

The following data is part of a premarket notification filed by Signature Orthopaedics Pty Ltd. with the FDA for Imboki Knee Instrument System.

Pre-market Notification Details

Device IDK181338
510k NumberK181338
Device Name:Imboki Knee Instrument System
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Signature Orthopaedics Pty Ltd. 7 Sirius Road Lane Cove,  AU 2066
ContactDeclan Brazil
CorrespondentDeclan Brazil
Signature Orthopaedics Pty Ltd. 7 Sirius Road Lane Cove,  AU 2066
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-21
Decision Date2019-01-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09348215046392 K181338 000
09348215031718 K181338 000
09348215046194 K181338 000
09348215046248 K181338 000
09348215046279 K181338 000
09348215046378 K181338 000
09348215046408 K181338 000
09348215031633 K181338 000
09348215046200 K181338 000
09348215046217 K181338 000
09348215046224 K181338 000
09348215046231 K181338 000
09348215046255 K181338 000
09348215031664 K181338 000

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