Fusion Ceramic Head 36mm

GUDID 09348215080938

SIGNATURE ORTHOPAEDICS PTY LTD

Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis
Primary Device ID09348215080938
NIH Device Record Key17995c1a-916f-46c8-8f39-48edaa79ea99
Commercial Distribution StatusIn Commercial Distribution
Brand NameFusion Ceramic Head 36mm
Version Model Number111-22-0513
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
GS109348215080938 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

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09348215025861 - Fusion Taper Sleeve +8mm2021-05-03
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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