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 ID: K211742
• 510k Number: K211742
• Device Name: SignaSure Dual Mobility System
• Classification: Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
• Applicant: Signature Orthopaedics Pty Ltd. 7 Sirius Road Lane Cove, AU 2066
• Contact: Declan Brazil
• Correspondent: Declan Brazil; Signature Orthopaedics Pty Ltd. 7 Sirius Road Lane Cove, AU 2066
• Product Code: MEH
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-06-07
• Decision Date: 2022-01-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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