BKS TriMax

GUDID 00822409006533

LT Size 2 PS Femoral Nonporous

Ortho Development Corporation

Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic

• Primary Device ID: 00822409006533
• NIH Device Record Key: 11287e76-5d4e-497d-9f7f-f4c7a12059b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BKS TriMax
• Version Model Number: 165-1201
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00822409006533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123457

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: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2015-08-31

On-Brand Devices [BKS TriMax]

• 00822409031436: RT Size 7 Femoral CR Nonporous
• 00822409031429: LT Size 7 Femoral CR Nonporous
• 00822409031412: RT Size 6 Femoral CR Nonporous
• 00822409031405: LT Size 6 Femoral CR Nonporous
• 00822409031399: RT Size 5 Narrow Femoral CR Nonporous
• 00822409031382: LT Size 5 Narrow Femoral CR Nonporous
• 00822409031375: RT Size 5 Femoral CR Nonporous
• 00822409031368: LT Size 5 Femoral CR Nonporous
• 00822409031351: RT Size 4 Narrow Femoral CR Nonporous
• 00822409031344: LT Size 4 Narrow Femoral CR Nonporous
• 00822409031337: RT Size 4 Femoral CR Nonporous
• 00822409031320: LT Size 4 Femoral CR Nonporous
• 00822409031313: RT Size 3.5 Femoral CR Nonporous
• 00822409031306: LT Size 3.5 Femoral CR Nonporous
• 00822409031290: RT Size 3 Femoral CR Nonporous
• 00822409031283: LT Size 3 Femoral CR Nonporous
• 00822409031276: RT Size 2.5 Femoral CR Nonporous
• 00822409031269: LT Size 2.5 Femoral CR Nonporous
• 00822409031252: RT Size 2 Femoral CR Nonporous
• 00822409031245: LT Size 2 Femoral CR Nonporous
• 00822409031238: RT Size 1 Femoral CR Nonporous
• 00822409031221: LT Size 1 Femoral CR Nonporous
• 00822409006724: RT Size 7 PS Femoral Nonporous
• 00822409006717: LT Size 7 PS Femoral Nonporous
• 00822409006700: RT Size 6 PS Femoral Nonporous
• 00822409006694: LT Size 6 PS Femoral Nonporous
• 00822409006687: RT Size 5 Narrow PS Femoral Nonporous
• 00822409006670: LT Size 5 Narrow PS Femoral Nonporous
• 00822409006663: RT Size 5 PS Femoral Nonporous
• 00822409006656: LT Size 5 PS Femoral Nonporous
• 00822409006649: RT Size 4 Narrow PS Femoral Nonporous
• 00822409006632: LT Size 4 Narrow PS Femoral Nonporous
• 00822409006625: RT Size 4 PS Femoral Nonporous
• 00822409006618: LT Size 4 PS Femoral Nonporous
• 00822409006601: RT Size 3.5 PS Femoral Nonporous
• 00822409006595: LT Size 3.5 PS Femoral Nonporous
• 00822409006588: RT Size 3 PS Femoral Nonporous
• 00822409006571: LT Size 3 PS Femoral Nonporous
• 00822409006564: RT Size 2.5 PS Femoral Nonporous
• 00822409006557: LT Size 2.5 PS Femoral Nonporous
• 00822409006540: RT Size 2 PS Femoral Nonporous
• 00822409006533: LT Size 2 PS Femoral Nonporous
• 00822409006526: RT Size 1 PS Femoral Nonporous
• 00822409006519: LT Size 1 PS Femoral Nonporous