Balanced Knee System

GUDID 00822409041114

PS Vitamin E Insert Sz 4 12mm

Ortho Development Corporation

Tibial insert

• Primary Device ID: 00822409041114
• NIH Device Record Key: 7d5a78ae-66c2-4366-822b-b8530ed9be28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Balanced Knee System
• Version Model Number: 163-5412
• 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

Device Dimensions

• Height: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409041114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994370

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: 2019-06-05
• Device Publish Date: 2019-05-28

On-Brand Devices [Balanced Knee System]

• 00822409035441: RT Size 3 Narrow Femoral CR Nonporous
• 00822409035434: LT Size 3 Narrow Femoral CR Nonporous
• 00822409035427: RT Size 4 Wide Femoral PS Nonporous
• 00822409035410: LT Size 4 Wide Femoral PS Nonporous
• 00822409035403: RT Size 3 Narrow Femoral PS Nonporous
• 00822409035397: LT Size 3 Narrow Femoral PS Nonporous
• 00822409030583: RT Size 7 Femoral CR Nonporous
• 00822409030576: LT Size 7 Femoral CR Nonporous
• 00822409030569: RT Size 6 Femoral CR Nonporous
• 00822409030552: LT Size 6 Femoral CR Nonporous
• 00822409030545: RT Size 5 Narrow Femoral CR Nonporous
• 00822409030538: LT Size 5 Narrow Femoral CR Nonporous
• 00822409030521: RT Size 5 Femoral CR Nonporous
• 00822409030514: LT Size 5 Femoral CR Nonporous
• 00822409030507: RT Size 4 Narrow Femoral CR Nonporous
• 00822409030491: LT Size 4 Narrow Femoral CR Nonporous
• 00822409030484: RT Size 4 Femoral CR Nonporous
• 00822409030477: LT Size 4 Femoral CR Nonporous
• 00822409030460: RT Size 3 Narrow Femoral CR Nonporous
• 00822409030453: LT Size 3 Narrow Femoral CR Nonporous
• 00822409030446: RT Size 3 Femoral CR Nonporous
• 00822409030439: LT Size 3 Femoral CR Nonporous
• 00822409030422: RT Size 2 Femoral CR Nonporous
• 00822409030415: LT Size 2 Femoral CR Nonporous
• 00822409030408: RT Size 1 Femoral CR Nonporous
• 00822409030392: LT Size 1 Femoral CR Nonporous
• 00822409030385: RT Size 7 Femoral PS-C Nonporous
• 00822409030378: LT Size 7 Femoral PS-C Nonporous
• 00822409030361: RT Size 7 Femoral PS Nonporous
• 00822409030354: LT Size 7 Femoral PS Nonporous
• 00822409030347: RT Size 6 Femoral PS-C Nonporous
• 00822409030330: LT Size 6 Femoral PS-C Nonporous
• 00822409030323: RT Size 6 Femoral PS Nonporous
• 00822409030316: LT Size 6 Femoral PS Nonporous
• 00822409030309: RT Size 5 Narrow Femoral PS Nonporous
• 00822409030293: LT Size 5 Narrow Femoral PS Nonporous
• 00822409030286: RT Size 5 Femoral PS-C Nonporous
• 00822409030279: LT Size 5 Femoral PS-C Nonporous
• 00822409030262: RT Size 5 Femoral PS Nonporous
• 00822409030255: LT Size 5 Femoral PS Nonporous
• 00822409030248: RT Size 4 Narrow Femoral PS Nonporous
• 00822409030231: LT Size 4 Narrow Femoral PS Nonporous
• 00822409030224: RT Size 4 Femoral PS-C Nonporous
• 00822409030217: LT Size 4 Femoral PS-C Nonporous
• 00822409030200: RT Size 4 Femoral PS Nonporous
• 00822409030194: LT Size 4 Femoral PS Nonporous
• 00822409030187: RT Size 3 Narrow Femoral PS Nonporous
• 00822409030170: LT Size 3 Narrow Femoral PS Nonporous
• 00822409030163: RT Size 3 Femoral PS-C Nonporous
• 00822409030156: LT Size 3 Femoral PS-C Nonporous