BKS Revision

GUDID 00822409103003

Neutral Tibial Tray Size 1

Ortho Development Corporation

Uncoated knee tibia prosthesis, metallic

• Primary Device ID: 00822409103003
• NIH Device Record Key: 358cd1fe-b9a0-4e0f-bd4a-6b0dfe3da3d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BKS Revision
• Version Model Number: 562-1100A
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409103003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031201

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/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: 2021-11-01
• Device Publish Date: 2021-10-22

On-Brand Devices [BKS Revision]

• 00822409110421: Modular Tibial Tray Neutral Size 7
• 00822409103065: Neutral Tibial Tray Size 7
• 00822409103058: Neutral Tibial Tray Size 6
• 00822409103041: Neutral Tibial Tray Size 5
• 00822409103034: Neutral Tibial Tray Size 4
• 00822409103027: Neutral Tibial Tray Size 3
• 00822409103010: Neutral Tibial Tray Size 2
• 00822409103003: Neutral Tibial Tray Size 1