Origin Hip Stem

GUDID 09348215051723

SIGNATURE ORTHOPAEDICS PTY LTD

Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular
Primary Device ID09348215051723
NIH Device Record Keyed928f6d-57cf-42f2-81f7-4b4b3d8cac54
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrigin Hip Stem
Version Model NumberD111-18-1802
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
GS109348215051723 [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 Date2022-09-28
Device Publish Date2022-09-20

On-Brand Devices [Origin Hip Stem]

09348215051822D111-18-1803
09348215051815D111-18-1603
09348215051808D111-18-1503
09348215051792D111-18-1403
09348215051785D111-18-1303
09348215051778D111-18-1203
09348215051761D111-18-1103
09348215051754D111-18-1003
09348215051747D111-18-0903
09348215051730D111-18-0803
09348215051723D111-18-1802
09348215051716D111-18-1602
09348215051709D111-18-1502
09348215051693D111-18-1402
09348215051686D111-18-1302
09348215051679D111-18-1202
09348215051662D111-18-1102
09348215051655D111-18-1002
09348215051648D111-18-0902
09348215051631D111-18-0802
09348215051624D111-18-1801
09348215051617D111-18-1601
09348215051600D111-18-1501
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