Aria Hip Stem

GUDID 09348215052843

SIGNATURE ORTHOPAEDICS PTY LTD

Coated hip femur prosthesis, modular
Primary Device ID09348215052843
NIH Device Record Keyad20835d-96c3-4b73-9c10-eb1578f3f3a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAria Hip Stem
Version Model NumberD111-20-6106
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
GS109348215052843 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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 [Aria Hip Stem]

09348215052904D111-20-6112
09348215052898D111-20-6111
09348215052881D111-20-6110
09348215052874D111-20-6109
09348215052867D111-20-6108
09348215052850D111-20-6107
09348215052843D111-20-6106
09348215052836D111-20-6105
09348215052829D111-20-6104
09348215052812D111-20-6103
09348215052805D111-20-6102
09348215052799D111-20-6101
09348215052782D111-20-6100
09348215052775D111-20-6012
09348215052768D111-20-6011
09348215052751D111-20-6010
09348215052744D111-20-6009
09348215052737D111-20-6008
09348215052720D111-20-6007
09348215052713D111-20-6006
09348215052706D111-20-6005
09348215052690D111-20-6004
09348215052683D111-20-6003
09348215052676D111-20-6002
09348215052669D111-20-6001
09348215052652D111-20-6000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.