Origin 125° Short Neck Collared Hip Stem

GUDID 09348215083564

SIGNATURE ORTHOPAEDICS PTY LTD

Coated femoral stem prosthesis, modular
Primary Device ID09348215083564
NIH Device Record Key0c055bfa-4c8e-4df1-9425-5deab13bd194
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrigin 125° Short Neck Collared Hip Stem
Version Model Number111-18-0826
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
GS109348215083564 [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 Date2022-03-16
Device Publish Date2022-03-08

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