Fusion Taper System

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

Signature Orthopaedics Pty Ltd.

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

Pre-market Notification Details

Device IDK201047
510k NumberK201047
Device Name:Fusion Taper System
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
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 CodeLZO  
Subsequent Product CodeMBL
Subsequent Product CodeMEH
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-21
Decision Date2021-04-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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09348215007836 K201047 000

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