BKS® Uni

GUDID 00822409120178

Tibial Tray Medial Nonporous Size 6 Right

Ortho Development Corporation

Uncoated knee tibia prosthesis, metallic

• Primary Device ID: 00822409120178
• NIH Device Record Key: 10ae97fc-91cf-4130-a6b3-f1ff8ea91a70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BKS® Uni
• Version Model Number: 762-6200A
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409120178 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211471

FDA Product Code

• HSX: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-04
• Device Publish Date: 2023-08-25

On-Brand Devices [BKS® Uni]

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