40-42mm BiPolar Head And 22mm Femoral Head

Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

SIGNATURE ORTHOPAEDICS PTY LTD.

The following data is part of a premarket notification filed by Signature Orthopaedics Pty Ltd. with the FDA for 40-42mm Bipolar Head And 22mm Femoral Head.

Pre-market Notification Details

Device IDK163081
510k NumberK163081
Device Name:40-42mm BiPolar Head And 22mm Femoral Head
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or 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 CodeKWY  
CFR Regulation Number888.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-03
Decision Date2018-01-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09348215017903 K163081 000
09348215112516 K163081 000
09348215112523 K163081 000
09348215045470 K163081 000
09348215017293 K163081 000
09348215017309 K163081 000
09348215017316 K163081 000
09348215017323 K163081 000
09348215072605 K163081 000
09348215072612 K163081 000
09348215072629 K163081 000
09348215072636 K163081 000
09348215072643 K163081 000
09348215072650 K163081 000
09348215072667 K163081 000
09348215072674 K163081 000
09348215017880 K163081 000
09348215017897 K163081 000
09348215112509 K163081 000

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