Balance Knee Revision System

GUDID 00822409004300

Size 2 12mm Tibial Insert CK

Ortho Development Corporation

Tibial insert

• Primary Device ID: 00822409004300
• NIH Device Record Key: 43e8a96e-f0f1-48b6-8bdb-902f140ee99d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Balance Knee Revision System
• Version Model Number: 563-1212
• 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 Dimensions

• Height: 12 Millimeter
• Height: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409004300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060569

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-31

On-Brand Devices [Balance Knee Revision System]

• 00822409006502: Size 6 Modular Tibial Tray Offset
• 00822409006496: Size 5 Modular Tibial Tray Offset
• 00822409006489: Size 4 Modular Tibial Tray Offset
• 00822409006472: Size 3 Modular Tibial Tray Offset
• 00822409006465: Size 2 Modular Tibial Tray Offset
• 00822409006458: Size 1 Modular Tibial Tray Offset
• 00822409006441: 7mm Offset Adapter
• 00822409006434: 5mm Offset Adapter
• 00822409006427: 3mm Offset Adapter
• 00822409006410: Offset Adapter Screw
• 00822409006403: 0mm Offset Adapter
• 00822409005628: Size 7 Femoral Augment Posterior 8mm
• 00822409005611: Size 7 Femoral Augment Posterior 4mm
• 00822409005604: Size 6 Femoral Augment Posterior 8mm
• 00822409005598: Size 6 Femoral Augment Posterior 4mm
• 00822409005581: Size 5 Femoral Augment Posterior 8mm
• 00822409005574: Size 5 Femoral Augment Posterior 4mm
• 00822409005567: Size 4 Femoral Augment Posterior 8mm
• 00822409005550: Size 4 Femoral Augment Posterior 4mm
• 00822409005543: Size 3 Femoral Augment Posterior 8mm
• 00822409005536: Size 3 Femoral Augment Posterior 4mm
• 00822409005529: Size 2 Femoral Augment Posterior 8mm
• 00822409005512: Size 2 Femoral Augment Posterior 4mm
• 00822409005505: Size 1 Femoral Augment Posterior 8mm
• 00822409005499: Size 1 Femoral Augment Posterior 4mm
• 00822409005482: Size 7 Femoral Augment Distal 12mm
• 00822409005475: Size 7 Femoral Augment Distal 8mm
• 00822409005468: Size 7 Femoral Augment Distal 4mm
• 00822409005451: Size 6 Femoral Augment Distal 12mm
• 00822409005444: Size 6 Femoral Augment Distal 8mm
• 00822409005437: Size 6 Femoral Augment Distal 4mm
• 00822409005420: Size 5 Femoral Augment Distal 12mm
• 00822409005413: Size 5 Femoral Augment Distal 8mm
• 00822409005406: Size 5 Femoral Augment Distal 4mm
• 00822409005390: Size 4 Femoral Augment Distal 12mm
• 00822409005383: Size 4 Femoral Augment Distal 8mm
• 00822409005376: Size 4 Femoral Augment Distal 4mm
• 00822409005369: Size 3 Femoral Augment Distal 12mm
• 00822409005352: Size 3 Femoral Augment Distal 8mm
• 00822409005345: Size 3 Femoral Augment Distal 4mm
• 00822409005338: Size 2 Femoral Augment Distal 12mm
• 00822409005321: Size 2 Femoral Augment Distal 8mm
• 00822409005314: Size 2 Femoral Augment Distal 4mm
• 00822409005307: Size 1 Femoral Augment Distal 8mm
• 00822409005291: Size 1 Femoral Augment Distal 4mm
• 00822409005284: Dia.24x150mm Stem Extension Fluted
• 00822409005277: Dia.24x110mm Stem Extension Fluted
• 00822409005260: Dia.24x80mm Stem Extension Fluted
• 00822409005253: Dia.22x150mm Stem Extension Fluted
• 00822409005246: Dia.22x110mm Stem Extension Fluted