Zimmer Biomet Patient Specific Instruments KNM-ZB02-00-01

GUDID 05420060310027

ZB MRI TKA Biomet Pin Guide kit

Materialise NV

Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit

• Primary Device ID: 05420060310027
• NIH Device Record Key: 66039879-9eca-4dc0-9613-c7b88d6faa13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zimmer Biomet Patient Specific Instruments
• Version Model Number: KNM-ZB02-00-01
• Catalog Number: KNM-ZB02-00-01
• Company DUNS: 373139427
• Company Name: Materialise NV
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05420060310027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173445

FDA Product Code

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

Sterilization

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

[05420060310027]

Moist Heat or Steam Sterilization

[05420060310027]

Moist Heat or Steam Sterilization

[05420060310027]

Moist Heat or Steam Sterilization

[05420060310027]

Moist Heat or Steam Sterilization

[05420060310027]

Moist Heat or Steam Sterilization

[05420060310027]

Moist Heat or Steam Sterilization

[05420060310027]

Moist Heat or Steam Sterilization

[05420060310027]

Moist Heat or Steam Sterilization

[05420060310027]

Moist Heat or Steam Sterilization

[05420060310027]

Moist Heat or Steam Sterilization

[05420060310027]

Moist Heat or Steam Sterilization

[05420060310027]

Moist Heat or Steam Sterilization

[05420060310027]

Moist Heat or Steam Sterilization

[05420060310027]

Moist Heat or Steam Sterilization

[05420060310027]

Moist Heat or Steam Sterilization

[05420060310027]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-27
• Device Publish Date: 2018-08-11

On-Brand Devices [Zimmer Biomet Patient Specific Instruments]

• 05420060310461: ZB CT TKA Biomet Spring Pin Guide kit
• 05420060310430: ZB CT TKA Biomet Spring Pin Guide and Bone Model kit
• 05420060310140: ZB CT TKA Zimmer Pin Guide kit
• 05420060310133: ZB CT TKA Zimmer Pin Guide and Bone Model kit
• 05420060310126: ZB CT TKA Biomet Pin Guide kit
• 05420060310119: ZB CT TKA Biomet Pin Guide and Bone Model kit
• 05420060310102: ZB MRI PKA ZUK Guide kit
• 05420060310096: ZB MRI PKA ZUK Guide and Bone Model kit
• 05420060310089: ZB MRI PKA Guide kit
• 05420060310072: ZB MRI PKA Guide and Bone Model kit
• 05420060310065: ZB MRI TKA Cut-through Guide kit
• 05420060310058: ZB MRI TKA Cut-through Guide and Bone Model kit
• 05420060310041: ZB MRI TKA Zimmer Pin Guide kit
• 05420060310034: ZB MRI TKA Zimmer Pin Guide and Bone Model kit
• 05420060310027: ZB MRI TKA Biomet Pin Guide kit
• 05420060310010: ZB MRI TKA Biomet Pin Guide and Bone Model kit