Fusion Taper Sleeve -2mm

GUDID 09348215062149

SIGNATURE ORTHOPAEDICS PTY LTD

Femoral head/stem prosthesis adaptor Femoral head/stem prosthesis adaptor Femoral head/stem prosthesis adaptor Femoral head/stem prosthesis adaptor Femoral head/stem prosthesis adaptor Femoral head/stem prosthesis adaptor Femoral head/stem prosthesis adaptor Femoral head/stem prosthesis adaptor Femoral head/stem prosthesis adaptor Femoral head/stem prosthesis adaptor Femoral head/stem prosthesis adaptor Femoral head/stem prosthesis adaptor Femoral head/stem prosthesis adaptor Femoral head/stem prosthesis adaptor Femoral head/stem prosthesis adaptor
Primary Device ID09348215062149
NIH Device Record Key55734026-deb1-45cf-870d-20b8e9f78170
Commercial Distribution StatusIn Commercial Distribution
Brand NameFusion Taper Sleeve -2mm
Version Model Number111-37-0006
Company DUNS751993028
Company NameSIGNATURE ORTHOPAEDICS PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109348215062149 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-03
Device Publish Date2021-04-23

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

09348215025830 - Fusion Taper Sleeve -4mm2021-05-03
09348215025847 - Fusion Taper Sleeve 0mm2021-05-03
09348215025854 - Fusion Taper Sleeve +4mm2021-05-03
09348215025861 - Fusion Taper Sleeve +8mm2021-05-03
09348215062149 - Fusion Taper Sleeve -2mm2021-05-03
09348215062149 - Fusion Taper Sleeve -2mm2021-05-03
09348215062156 - Fusion Taper Sleeve +2mm2021-05-03
09348215062163 - Fusion Taper Sleeve +6mm2021-05-03
09348215080891 - Fusion Taper Sleeve Remover Collett2021-05-03

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