BKS E-Vitalize

GUDID 00822409032976

Size 7 20mm Tibial Insert UC

Ortho Development Corporation

Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert

• Primary Device ID: 00822409032976
• NIH Device Record Key: 7eec8ad1-5b83-4465-b0c1-6ceb9d13fee0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BKS E-Vitalize
• Version Model Number: 166-7720
• Company DUNS: 876542390
• Company Name: Ortho Development Corporation
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com

Device Dimensions

• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409032976 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152169

FDA Product Code

• JWY: Manual antimicrobial susceptibility test systems
• OIY: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-12-21

On-Brand Devices [BKS E-Vitalize]

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