BKS E-Vitalize

GUDID 00822409007271

Size 5 12mm Tibial Insert PS, Vitamin E

Ortho Development Corporation

Tibial insert
Primary Device ID00822409007271
NIH Device Record Key5b1d7ca9-aa88-4864-a051-7524326f2d62
Commercial Distribution StatusIn Commercial Distribution
Brand NameBKS E-Vitalize
Version Model Number166-5512
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 Dimensions

Height12 Millimeter
Height12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100822409007271 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-08-31

On-Brand Devices [BKS E-Vitalize]

00822409032976Size 7 20mm Tibial Insert UC
00822409032969Size 7 18mm Tibial Insert UC
00822409032952Size 7 16mm Tibial Insert UC
00822409032945Size 7 14mm Tibial Insert UC
00822409032938Size 7 13mm Tibial Insert UC
00822409032921Size 7 12mm Tibial Insert UC
00822409032914Size 7 11mm Tibial Insert UC
00822409032907Size 7 10mm Tibial Insert UC
00822409032891Size 7 9mm Tibial Insert UC
00822409032884Size 7 8mm Tibial Insert UC
00822409032877Size 7 7mm Tibial Insert UC
00822409032860Size 6 20mm Tibial Insert UC
00822409032853Size 6 18mm Tibial Insert UC
00822409032846Size 6 16mm Tibial Insert UC
00822409032839Size 6 14mm Tibial Insert UC
00822409032822Size 6 13mm Tibial Insert UC
00822409032815Size 6 12mm Tibial Insert UC
00822409032808Size 6 11mm Tibial Insert UC
00822409032792Size 6 10mm Tibial Insert UC
00822409032785Size 6 9mm Tibial Insert UC
00822409032778Size 6 8mm Tibial Insert UC
00822409032761Size 6 7mm Tibial Insert UC
00822409032754Size 5 20mm Tibial Insert UC
00822409032747Size 5 18mm Tibial Insert UC
00822409032730Size 5 16mm Tibial Insert UC
00822409032723Size 5 14mm Tibial Insert UC
00822409032716Size 5 13mm Tibial Insert UC
00822409032709Size 5 12mm Tibial Insert UC
00822409032693Size 5 11mm Tibial Insert UC
00822409032686Size 5 10mm Tibial Insert UC
00822409032679Size 5 9mm Tibial Insert UC
00822409032662Size 5 8mm Tibial Insert UC
00822409032655Size 5 7mm Tibial Insert UC
00822409032648Size 4 20mm Tibial Insert UC
00822409032631Size 4 18mm Tibial Insert UC
00822409032624Size 4 16mm Tibial Insert UC
00822409032617Size 4 14mm Tibial Insert UC
00822409032600Size 4 13mm Tibial Insert UC
00822409032594Size 4 12mm Tibial Insert UC
00822409032587Size 4 11mm Tibial Insert UC
00822409032570Size 4 10mm Tibial Insert UC
00822409032563Size 4 9mm Tibial Insert UC
00822409032556Size 4 8mm Tibial Insert UC
00822409032549Size 4 7mm Tibial Insert UC
00822409032532Size 3 20mm Tibial Insert UC
00822409032525Size 3 18mm Tibial Insert UC
00822409032518Size 3 16mm Tibial Insert UC
00822409032501Size 3 14mm Tibial Insert UC
00822409032495Size 3 13mm Tibial Insert UC
00822409032488Size 3 12mm Tibial Insert UC

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