World Knee Vit-E CR All Poly Tibia

GUDID 09348215089443

SIGNATURE ORTHOPAEDICS PTY LTD

Uncoated knee tibia prosthesis, polyethylene
Primary Device ID09348215089443
NIH Device Record Key83a70a7b-d03d-4eaa-8827-2cd0ba7248e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameWorld Knee Vit-E CR All Poly Tibia
Version Model Number121-20-6458
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
GS109348215089443 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-02
Device Publish Date2023-07-25

On-Brand Devices [World Knee Vit-E CR All Poly Tibia]

09348215089733121-20-6956
09348215089726121-20-6954
09348215089719121-20-6952
09348215089702121-20-6950
09348215089665121-20-6854
09348215089658121-20-6852
09348215089641121-20-6850
09348215089610121-20-6756
09348215089603121-20-6754
09348215089597121-20-6752
09348215089580121-20-6750
09348215089559121-20-6656
09348215089542121-20-6654
09348215089535121-20-6652
09348215089528121-20-6650
09348215089498121-20-6556
09348215089481121-20-6554
09348215089474121-20-6552
09348215089467121-20-6550
09348215089436121-20-6456
09348215089429121-20-6454
09348215089412121-20-6452
09348215089405121-20-6450
09348215089375121-20-6356
09348215089368121-20-6354
09348215089351121-20-6352
09348215089344121-20-6350
09348215089313121-20-6256
09348215089306121-20-6254
09348215089290121-20-6252
09348215089283121-20-6250
09348215089252121-20-6156
09348215089245121-20-6154
09348215089238121-20-6152
09348215089221121-20-6150
09348215089757121-20-6959
09348215089740121-20-6958
09348215089696121-20-6859
09348215089689121-20-6858
09348215089634121-20-6759
09348215089627121-20-6758
09348215089573121-20-6659
09348215089566121-20-6658
09348215089511121-20-6559
09348215089504121-20-6558
09348215089450121-20-6459
09348215089443121-20-6458
09348215089399121-20-6359
09348215089382121-20-6358
09348215089337121-20-6259

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