Ligament Balancing Block

GUDID 09348215046279

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 09348215046279
• NIH Device Record Key: b76405c4-f207-4cd1-b8da-b7c5f21f22d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ligament Balancing Block
• Version Model Number: 122-16-0354
• Company DUNS: 751993028
• Company Name: SIGNATURE ORTHOPAEDICS PTY LTD
• 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	09348215046279 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181338

FDA Product Code

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

Sterilization

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

[09348215046279]

Moist Heat or Steam Sterilization

[09348215046279]

Moist Heat or Steam Sterilization

[09348215046279]

Moist Heat or Steam Sterilization

[09348215046279]

Moist Heat or Steam Sterilization

[09348215046279]

Moist Heat or Steam Sterilization

[09348215046279]

Moist Heat or Steam Sterilization

[09348215046279]

Moist Heat or Steam Sterilization

[09348215046279]

Moist Heat or Steam Sterilization

[09348215046279]

Moist Heat or Steam Sterilization

[09348215046279]

Moist Heat or Steam Sterilization

[09348215046279]

Moist Heat or Steam Sterilization

[09348215046279]

Moist Heat or Steam Sterilization

[09348215046279]

Moist Heat or Steam Sterilization

[09348215046279]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-03
• Device Publish Date: 2019-02-18

On-Brand Devices [Ligament Balancing Block]

• 09348215041304: 122-10-0233
• 09348215056766: 122-102-231
• 09348215062002: 122-18-0397
• 09348215074029: 122-15-0233
• 09348215046279: 122-16-0354