N/A

GUDID 00822409119479

Uni E-Vitalize Tibial Insert Trial Symmetric Size 2 11mm

Ortho Development Corporation

Knee tibia prosthesis trial, reusable

• Primary Device ID: 00822409119479
• NIH Device Record Key: 504012c4-306f-4e67-ada6-30d809e4f42e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 863-2011
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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
• 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 Dimensions

• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409119479 [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: true
• Device Is Sterile: false

[00822409119479]

Moist Heat or Steam Sterilization

[00822409119479]

Moist Heat or Steam Sterilization

[00822409119479]

Moist Heat or Steam Sterilization

[00822409119479]

Moist Heat or Steam Sterilization

[00822409119479]

Moist Heat or Steam Sterilization

[00822409119479]

Moist Heat or Steam Sterilization

[00822409119479]

Moist Heat or Steam Sterilization

[00822409119479]

Moist Heat or Steam Sterilization

[00822409119479]

Moist Heat or Steam Sterilization

[00822409119479]

Moist Heat or Steam Sterilization

[00822409119479]

Moist Heat or Steam Sterilization

[00822409119479]

Moist Heat or Steam Sterilization

[00822409119479]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-18
• Device Publish Date: 2023-09-08

On-Brand Devices [N/A]

• 00822409045082: Straight Anterior Broach Handle
• 00822409044474: CR Insert Trials Size 6
• 00822409044467: CR Insert Trials Size 6
• 00822409044450: CR Insert Trials Size 6
• 00822409044443: CR Insert Trials Size 6
• 00822409044436: CR Insert Trials Size 5
• 00822409044429: CR Insert Trials Size 5
• 00822409044412: CR Insert Trials Size 5
• 00822409044405: CR Insert Trials Size 5
• 00822409044399: CR Insert Trials Size 4
• 00822409044382: CR Insert Trials Size 4
• 00822409044375: CR Insert Trials Size 4
• 00822409044368: CR Insert Trials Size 4
• 00822409044351: CR Insert Trials Size 3
• 00822409044344: CR Insert Trials Size 3
• 00822409044337: CR Insert Trials Size 3
• 00822409044320: CR Insert Trials Size 3
• 00822409044313: CR Insert Trials Size 2
• 00822409044306: CR Insert Trials Size 2
• 00822409044290: CR Insert Trials Size 2
• 00822409044283: CR Insert Trials Size 2
• 00822409044276: Wingnut Patella Reaming Handle
• 00822409046546: Single Offset Broach Handle
• 00822409046539: 2mm Tibial Recut Block
• 00822409071630: Threaded Collarless Pin 50mm
• 00822409071623: Threaded Collared Pin 50mm
• 00822409071272: TibTrialSpacer Lg Height 30mm
• 00822409071265: TibTrialSpacer Lg Height 25mm
• 00822409071258: TibTrialSpacer Lg Height 20mm
• 00822409071241: TibTrialSpacer Lg Height18mm
• 00822409071234: TibTrialSpacer Lg Height16mm
• 00822409071227: TibTrialSpacer Lg Height14mm
• 00822409071210: TibTrialSpacer Lg Height12mm
• 00822409071203: TibTrialSpacer Lg Height10mm
• 00822409071197: TibTrialSpacer Med Height30mm
• 00822409071180: TibTrialSpacer Med Height25mm
• 00822409071173: TibTrialSpacer Med Height20mm
• 00822409071166: TibTrialSpacer Med Height18mm
• 00822409071159: TibTrialSpacer Med Height16mm
• 00822409071142: TibTrialSpacer Med Height14mm
• 00822409071135: TibTrialSpacer Med Height12mm
• 00822409071128: TibTrialSpacer Med Height10mm
• 00822409071111: TibTrialSpacerSmall Height30mm
• 00822409071104: TibTrialSpacerSmall Height25mm
• 00822409071098: TibTrialSpacerSmall Height20mm
• 00822409071081: TibTrialSpacerSmall Height18mm
• 00822409071074: TibTrialSpacerSmall Height16mm
• 00822409071067: TibTrialSpacerSmall Height14mm
• 00822409071050: TibTrialSpacerSmall Height12mm
• 00822409071043: TibTrialSpacerSmall Height10mm