K Knee 9069.10.285

GUDID 08033390066228

Long Pins for Trial Tibial Plates - PHYSICA & MULTIGEN PLUS

LIMACORPORATE SPA

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 08033390066228
• NIH Device Record Key: a61263a9-9ca4-4ba6-9f64-68c903f6b5b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K Knee
• Version Model Number: Long Pins for Trial Tibial Plates
• Catalog Number: 9069.10.285
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390066228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141934

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

[08033390066228]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-05
• Device Publish Date: 2016-08-05

On-Brand Devices [K Knee]

• 08033390066228: Long Pins for Trial Tibial Plates - PHYSICA & MULTIGEN PLUS
• 08033390026819: Pins for Trial Tibial Plates - PHYSICA & MULTIGEN PLUS