Adjustable Rotator Setter

GUDID 09348215046248

SIGNATURE ORTHOPAEDICS PTY LTD

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• Primary Device ID: 09348215046248
• NIH Device Record Key: d3851c56-9b67-4afc-9419-09e5bccb9611
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adjustable Rotator Setter
• Version Model Number: 122-16-0386
• 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	09348215046248 [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

[09348215046248]

Moist Heat or Steam Sterilization

[09348215046248]

Moist Heat or Steam Sterilization

[09348215046248]

Moist Heat or Steam Sterilization

[09348215046248]

Moist Heat or Steam Sterilization

[09348215046248]

Moist Heat or Steam Sterilization

[09348215046248]

Moist Heat or Steam Sterilization

[09348215046248]

Moist Heat or Steam Sterilization

[09348215046248]

Moist Heat or Steam Sterilization

[09348215046248]

Moist Heat or Steam Sterilization

[09348215046248]

Moist Heat or Steam Sterilization

[09348215046248]

Moist Heat or Steam Sterilization

[09348215046248]

Moist Heat or Steam Sterilization

[09348215046248]

Moist Heat or Steam Sterilization

[09348215046248]

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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• 09348215129255 - Verteloc Lumbar Cage: 2024-03-20
• 09348215129262 - Verteloc Lumbar Cage: 2024-03-20
• 09348215129279 - Verteloc Lumbar Cage: 2024-03-20
• 09348215129286 - Verteloc Lumbar Cage: 2024-03-20
• 09348215129293 - Verteloc Lumbar Cage: 2024-03-20