World Knee Spherical Patella – Finned Peg Vit-E

GUDID 09348215134303

SIGNATURE ORTHOPAEDICS PTY LTD

Polyethylene patella prosthesis
Primary Device ID09348215134303
NIH Device Record Key562e5173-88c7-4ed3-9f1e-450e0324ab6b
Commercial Distribution StatusIn Commercial Distribution
Brand NameWorld Knee Spherical Patella – Finned Peg Vit-E
Version Model Number121-20-8420E
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
GS109348215134303 [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 Date2024-10-16
Device Publish Date2024-10-08

On-Brand Devices [World Knee Spherical Patella – Finned Peg Vit-E ]

09348215134242121-20-8921E
09348215134235121-20-8020E
09348215134334121-20-8620E
09348215134327121-20-8520E
09348215134310121-20-8924E
09348215134303121-20-8420E
09348215134297121-20-8923E
09348215134280121-20-8320E
09348215134273121-20-8220E
09348215134266121-20-8922E
09348215134259121-20-8120E

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