World Knee Vit-E CR Poly Insert

GUDID 09348215091538

SIGNATURE ORTHOPAEDICS PTY LTD

Tibial insert
Primary Device ID09348215091538
NIH Device Record Key2451c41d-1cd1-48bc-8b1e-29340631a131
Commercial Distribution StatusIn Commercial Distribution
Brand NameWorld Knee Vit-E CR Poly Insert
Version Model Number121-20-7556
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
GS109348215091538 [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 Date2022-05-09
Device Publish Date2022-04-29

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

09348215091910121-20-7958
09348215091903121-20-7957
09348215091897121-20-7956
09348215091880121-20-7955
09348215091873121-20-7954
09348215091866121-20-7953
09348215091859121-20-7952
09348215091842121-20-7951
09348215091835121-20-7950
09348215091828121-20-7858
09348215091811121-20-7857
09348215091804121-20-7856
09348215091798121-20-7855
09348215091781121-20-7854
09348215091774121-20-7853
09348215091767121-20-7852
09348215091750121-20-7851
09348215091743121-20-7850
09348215091736121-20-7758
09348215091729121-20-7757
09348215091712121-20-7756
09348215091705121-20-7755
09348215091699121-20-7754
09348215091682121-20-7753
09348215091675121-20-7752
09348215091668121-20-7751
09348215091651121-20-7750
09348215091644121-20-7658
09348215091637121-20-7657
09348215091620121-20-7656
09348215091613121-20-7655
09348215091606121-20-7654
09348215091590121-20-7653
09348215091583121-20-7652
09348215091576121-20-7651
09348215091569121-20-7650
09348215091552121-20-7558
09348215091545121-20-7557
09348215091538121-20-7556
09348215091521121-20-7555
09348215091514121-20-7554
09348215091507121-20-7553
09348215091491121-20-7552
09348215091484121-20-7551
09348215091477121-20-7550
09348215091460121-20-7458
09348215091453121-20-7457
09348215091446121-20-7456
09348215091439121-20-7455
09348215091422121-20-7454

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