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
09348215082246 K201047 000
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09348215062163 K201047 000
09348215062156 K201047 000
09348215062149 K201047 000
09348215025861 K201047 000
09348215025854 K201047 000
09348215025847 K201047 000
09348215080938 K201047 000
09348215082154 K201047 000
09348215082239 K201047 000
09348215082222 K201047 000
09348215082215 K201047 000
09348215082208 K201047 000
09348215082192 K201047 000
09348215082185 K201047 000
09348215082178 K201047 000
09348215082161 K201047 000
09348215025830 K201047 000

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