Balanced Knee Revision System

GUDID 00822409038107

Constrained Tibial Insert Sz 1 14mm

Ortho Development Corporation

Tibial insert

• Primary Device ID: 00822409038107
• NIH Device Record Key: fe3eb1f8-3dbd-43f0-b3d9-41c6d6f705ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Balanced Knee Revision System
• Version Model Number: 563-2114
• Company DUNS: 876542390
• Company Name: Ortho Development Corporation
• Device Count: 1
• DM Exempt: false
• 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: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409038107 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-07
• Device Publish Date: 2018-11-06

On-Brand Devices [Balanced Knee Revision System]

• 00822409040728: Slotted Stem Ext Diameter 24mm x 150mm
• 00822409040711: Slotted Stem Ext Diameter 24mm x 110mm
• 00822409040704: Slotted Stem Ext Diameter 24mm x 80mm
• 00822409040698: Slotted Stem Ext Diameter 22mm x 150mm
• 00822409040681: Slotted Stem Ext Diameter 22mm x 110mm
• 00822409040674: Slotted Stem Ext Diameter 22mm x 80mm
• 00822409040667: Slotted Stem Ext Diameter 20mm x 150mm
• 00822409040650: Slotted Stem Ext Diameter 20mm x 110mm
• 00822409040643: Slotted Stem Ext Diameter 20mm x 80mm
• 00822409040636: Slotted Stem Ext Diameter 19mm x 150mm
• 00822409040629: Slotted Stem Ext Diameter 19mm x 110mm
• 00822409040612: Slotted Stem Ext Diameter 19mm x 80mm
• 00822409040605: Slotted Stem Ext Diameter 18mm x 150mm
• 00822409040599: Slotted Stem Ext Diameter 18mm x 110mm
• 00822409040582: Slotted Stem Ext Diameter 18mm x 80mm
• 00822409040575: Slotted Stem Ext Diameter 17mm x 150mm
• 00822409040568: Slotted Stem Ext Diameter 17mm x 110mm
• 00822409040551: Slotted Stem Ext Diameter 17mm x 80mm
• 00822409040544: Slotted Stem Ext Diameter 16mm x 150mm
• 00822409040537: Slotted Stem Ext Diameter 16mm x 110mm
• 00822409040520: Slotted Stem Ext Diameter 16mm x 80mm
• 00822409040513: Slotted Stem Ext Diameter 15mm x 150mm
• 00822409040506: Slotted Stem Ext Diameter 15mm x 110mm
• 00822409040490: Slotted Stem Ext Diameter 15mm x 80mm
• 00822409040483: Slotted Stem Ext Diameter 14mm x 150mm
• 00822409040476: Slotted Stem Ext Diameter 14mm x 110mm
• 00822409040469: Slotted Stem Ext Diameter 14mm x 80mm
• 00822409040452: Fluted Stem Ext Diameter 13mm x 150mm
• 00822409040445: Fluted Stem Ext Diameter 13mm x 110mm
• 00822409040438: Fluted Stem Ext Diameter 13mm x 80mm
• 00822409040421: Fluted Stem Ext Diameter 12mm x 150mm
• 00822409040414: Fluted Stem Ext Diameter 12mm x 110mm
• 00822409040407: Fluted Stem Ext Diameter 12mm x 80mm
• 00822409040391: Fluted Stem Ext Diameter 11mm x 150mm
• 00822409040384: Fluted Stem Ext Diameter 11mm x 110mm
• 00822409040377: Fluted Stem Ext Diameter 11mm x 80mm
• 00822409040360: Fluted Stem Ext Diameter 10mm x 150mm
• 00822409040353: Fluted Stem Ext Diameter 10mm x 110mm
• 00822409040346: Fluted Stem Ext Diameter 10mm x 80mm
• 00822409040339: Offset Tibial Tray Sz 7
• 00822409040322: Offset Tibial Tray Sz 6
• 00822409040315: Offset Tibial Tray Sz 5
• 00822409040308: Offset Tibial Tray Sz 4
• 00822409040292: Offset Tibial Tray Sz 3
• 00822409040285: Offset Tibial Tray Sz 2
• 00822409040278: Offset Tibial Tray Sz 1
• 00822409040261: Sloped Tibial Tray Size 7
• 00822409040254: Sloped Tibial Tray Size 6
• 00822409040247: Sloped Tibial Tray Size 5
• 00822409040230: Sloped Tibial Tray Size 4