Rx Knee Universal Tibial Stem Adapter Screw

GUDID 09348215112363

SIGNATURE ORTHOPAEDICS PTY LTD

Temporary knee prosthesis, non-customized
Primary Device ID09348215112363
NIH Device Record Key80e409e1-3c07-4a14-88a9-ee0777c94801
Commercial Distribution StatusIn Commercial Distribution
Brand NameRx Knee Universal Tibial Stem Adapter Screw
Version Model Number121-20-9153
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
GS109348215112363 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-20
Device Publish Date2024-11-12

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

09348215110246 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20
09348215110253 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20
09348215110260 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20
09348215110277 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20
09348215110284 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20
09348215110291 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20
09348215110307 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20
09348215110314 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20

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