SignaSure Dual Mobility System

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

Signature Orthopaedics Pty Ltd.

The following data is part of a premarket notification filed by Signature Orthopaedics Pty Ltd. with the FDA for Signasure Dual Mobility System.

Pre-market Notification Details

Device IDK211742
510k NumberK211742
Device Name:SignaSure Dual Mobility System
ClassificationProsthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
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 CodeMEH  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-07
Decision Date2022-01-07

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.