BKS® Uni

GUDID 00822409120093

Tibial Tray Medial Nonporous Size 2 Right

Ortho Development Corporation

Uncoated knee tibia prosthesis, metallic
Primary Device ID00822409120093
NIH Device Record Key253717f0-7c31-4d7e-9f58-bace13d43b8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBKS® Uni
Version Model Number762-2200A
Company DUNS876542390
Company NameOrtho Development Corporation
Device Count1
DM Exempttrue
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100822409120093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-04
Device Publish Date2023-08-25

On-Brand Devices [BKS® Uni]

00822409110407Tibial Insert Medial Right Size 8 11mm
00822409110391Tibial Insert Medial Left Size 8 11mm
00822409110384Tibial Insert Medial Right Size 8 10mm
00822409110377Tibial Insert Medial Left Size 8 10mm
00822409110360Tibial Insert Medial Right Size 8 9mm
00822409110353Tibial Insert Medial Left Size 8 9mm
00822409110346Tibial Insert Medial Right Size 8 8mm
00822409110339Tibial Insert Medial Left Size 8 8mm
00822409110322Tibial Insert Medial Right Size 8 7mm
00822409110315Tibial Insert Medial Left Size 8 7mm
00822409110308Tibial Insert Medial Right Size 8 6mm
00822409110292Tibial Insert Medial Left Size 8 6mm
00822409110285Tibial Insert Medial Right Size 7 11mm
00822409110278Tibial Insert Medial Left Size 7 11mm
00822409110261Tibial Insert Medial Right Size 7 10mm
00822409110254Tibial Insert Medial Left Size 7 10mm
00822409110247Tibial Insert Medial Right Size 7 9mm
00822409110230Tibial Insert Medial Left Size 7 9mm
00822409110223Tibial Insert Medial Right Size 7 8mm
00822409110216Tibial Insert Medial Left Size 7 8mm
00822409110209Tibial Insert Medial Right Size 7 7mm
00822409110193Tibial Insert Medial Left Size 7 7mm
00822409110186Tibial Insert Medial Right Size 7 6mm
00822409110179Tibial Insert Medial Left Size 7 6mm
00822409110162Tibial Insert Medial Right Size 6 11mm
00822409110155Tibial Insert Medial Left Size 6 11mm
00822409110148Tibial Insert Medial Right Size 6 10mm
00822409110131Tibial Insert Medial Left Size 6 10mm
00822409110124Tibial Insert Medial Right Size 6 9mm
00822409110117Tibial Insert Medial Left Size 6 9mm
00822409110100Tibial Insert Medial Right Size 6 8mm
00822409110094Tibial Insert Medial Left Size 6 8mm
00822409110087Tibial Insert Medial Right Size 6 7mm
00822409110070Tibial Insert Medial Left Size 6 7mm
00822409110063Tibial Insert Medial Right Size 6 6mm
00822409110056Tibial Insert Medial Left Size 6 6mm
00822409110049Tibial Insert Medial Right Size 5 11mm
00822409110032Tibial Insert Medial Left Size 5 11mm
00822409110025Tibial Insert Medial Right Size 5 10mm
00822409110018Tibial Insert Medial Left Size 5 10mm
00822409110001Tibial Insert Medial Right Size 5 9mm
00822409109999Tibial Insert Medial Left Size 5 9mm
00822409109982Tibial Insert Medial Right Size 5 8mm
00822409109975Tibial Insert Medial Left Size 5 8mm
00822409109968Tibial Insert Medial Right Size 5 7mm
00822409109951Tibial Insert Medial Left Size 5 7mm
00822409109944Tibial Insert Medial Right Size 5 6mm
00822409109937Tibial Insert Medial Left Size 5 6mm
00822409109920Tibial Insert Medial Right Size 4 11mm
00822409109913Tibial Insert Medial Left Size 4 11mm

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