IM Rod

GUDID 09348215046194

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 09348215046194
• NIH Device Record Key: d899dd78-7aff-4c12-997a-a56fbff62996
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IM Rod
• Version Model Number: 122-16-0323
• 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	09348215046194 [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

[09348215046194]

Moist Heat or Steam Sterilization

[09348215046194]

Moist Heat or Steam Sterilization

[09348215046194]

Moist Heat or Steam Sterilization

[09348215046194]

Moist Heat or Steam Sterilization

[09348215046194]

Moist Heat or Steam Sterilization

[09348215046194]

Moist Heat or Steam Sterilization

[09348215046194]

Moist Heat or Steam Sterilization

[09348215046194]

Moist Heat or Steam Sterilization

[09348215046194]

Moist Heat or Steam Sterilization

[09348215046194]

Moist Heat or Steam Sterilization

[09348215046194]

Moist Heat or Steam Sterilization

[09348215046194]

Moist Heat or Steam Sterilization

[09348215046194]

Moist Heat or Steam Sterilization

[09348215046194]

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

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

• 09348215129224 - Verteloc Lumbar Cage: 2024-03-20
• 09348215129231 - Verteloc Lumbar Cage: 2024-03-20
• 09348215129248 - Verteloc Lumbar Cage: 2024-03-20
• 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