PHYSICA ZUK 9061.20.060

GUDID 08033390128643

Tibial EM Guide Ankle Clamp

LIMACORPORATE SPA

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 08033390128643
• NIH Device Record Key: fd974a73-7447-483a-ac5d-26f9b3146e68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHYSICA ZUK
• Version Model Number: 9061.20.060
• Catalog Number: 9061.20.060
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	08033390128643 [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

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

[08033390128643]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-11
• Device Publish Date: 2022-08-03

On-Brand Devices [PHYSICA ZUK]

• 08033390128667: Tibial EM Guide Height Adjuster
• 08033390128650: Tibial EM Guide Slope Adjuster
• 08033390128643: Tibial EM Guide Ankle Clamp