Rx Knee Femoral Trial PS Size 4

GUDID 09348215148119

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215148119
NIH Device Record Key54f828cc-7911-47f4-9872-4cf6343a2414
Commercial Distribution StatusIn Commercial Distribution
Brand NameRx Knee Femoral Trial PS Size 4
Version Model Number122-23-0204
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109348215148119 [Primary]

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215148119]

Moist Heat or Steam Sterilization


[09348215148119]

Moist Heat or Steam Sterilization


[09348215148119]

Moist Heat or Steam Sterilization


[09348215148119]

Moist Heat or Steam Sterilization


[09348215148119]

Moist Heat or Steam Sterilization


[09348215148119]

Moist Heat or Steam Sterilization


[09348215148119]

Moist Heat or Steam Sterilization


[09348215148119]

Moist Heat or Steam Sterilization


[09348215148119]

Moist Heat or Steam Sterilization


[09348215148119]

Moist Heat or Steam Sterilization


[09348215148119]

Moist Heat or Steam Sterilization


[09348215148119]

Moist Heat or Steam Sterilization


[09348215148119]

Moist Heat or Steam Sterilization


[09348215148119]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-03
Device Publish Date2025-08-26

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

09348215148898 - Rx Knee Femoral Box Cut Guide Size 1 - 22025-09-04
09348215148904 - Rx Knee Femoral Box Cut Guide Size 3 - 42025-09-04
09348215148911 - Rx Knee Femoral Box Cut Guide Size 5- 62025-09-04
09348215148928 - Rx Knee Femoral Box Cut Guide Size 7 - 82025-09-04
09348215148935 - Rx Knee Femoral Box Cut Guide Size 9 - 92025-09-04
09348215117658 - Patella Sizer2025-09-03
09348215117665 - Ligament Balancing Block Size 10-122025-09-03
09348215117672 - Ligament Balancing Block Size 14-162025-09-03

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.