The Block

GUDID 09348215046378

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 09348215046378
• NIH Device Record Key: fc1c1213-ec61-428f-9343-fc45c5cff27c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The Block
• Version Model Number: 122-16-0327
• 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	09348215046378 [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

[09348215046378]

Moist Heat or Steam Sterilization

[09348215046378]

Moist Heat or Steam Sterilization

[09348215046378]

Moist Heat or Steam Sterilization

[09348215046378]

Moist Heat or Steam Sterilization

[09348215046378]

Moist Heat or Steam Sterilization

[09348215046378]

Moist Heat or Steam Sterilization

[09348215046378]

Moist Heat or Steam Sterilization

[09348215046378]

Moist Heat or Steam Sterilization

[09348215046378]

Moist Heat or Steam Sterilization

[09348215046378]

Moist Heat or Steam Sterilization

[09348215046378]

Moist Heat or Steam Sterilization

[09348215046378]

Moist Heat or Steam Sterilization

[09348215046378]

Moist Heat or Steam Sterilization

[09348215046378]

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

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• 09348215110260 - Rx Knee All Poly Tibia Augment - Full - 4mm: 2024-11-20
• 09348215110277 - Rx Knee All Poly Tibia Augment - Full - 4mm: 2024-11-20
• 09348215110284 - Rx Knee All Poly Tibia Augment - Full - 4mm: 2024-11-20
• 09348215110291 - Rx Knee All Poly Tibia Augment - Full - 4mm: 2024-11-20
• 09348215110307 - Rx Knee All Poly Tibia Augment - Full - 4mm: 2024-11-20
• 09348215110314 - Rx Knee All Poly Tibia Augment - Full - 4mm: 2024-11-20