Modular Keel Punch

GUDID 09348215117726

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID09348215117726
NIH Device Record Keyb87c96f3-4add-4f6d-8d6d-93fe30df5ab5
Commercial Distribution StatusIn Commercial Distribution
Brand NameModular Keel Punch
Version Model Number122-18-1550
Company DUNS751993028
Company NameSIGNATURE ORTHOPAEDICS PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
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
GS109348215117726 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215117726]

Moist Heat or Steam Sterilization


[09348215117726]

Moist Heat or Steam Sterilization


[09348215117726]

Moist Heat or Steam Sterilization


[09348215117726]

Moist Heat or Steam Sterilization


[09348215117726]

Moist Heat or Steam Sterilization


[09348215117726]

Moist Heat or Steam Sterilization


[09348215117726]

Moist Heat or Steam Sterilization


[09348215117726]

Moist Heat or Steam Sterilization


[09348215117726]

Moist Heat or Steam Sterilization


[09348215117726]

Moist Heat or Steam Sterilization


[09348215117726]

Moist Heat or Steam Sterilization


[09348215117726]

Moist Heat or Steam Sterilization


[09348215117726]

Moist Heat or Steam Sterilization


[09348215117726]

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.