Verteloc Spinal System

GUDID 09348215129002

SIGNATURE ORTHOPAEDICS PTY LTD

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• Primary Device ID: 09348215129002
• NIH Device Record Key: 9d37cf30-14bc-408e-82d1-1d374452f227
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Verteloc Spinal System
• Version Model Number: 131-14-1013
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09348215129002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231134

FDA Product Code

• PLR: Spinal Vertebral Body Replacement Device - Cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-12
• Device Publish Date: 2024-03-04

On-Brand Devices [Verteloc Spinal System]

• 09348215129132: 131-14-0040
• 09348215129125: 131-14-0030
• 09348215129118: 131-14-0020
• 09348215129101: 131-14-0010
• 09348215129095: 131-14-0008
• 09348215129088: 131-14-1713
• 09348215129071: 131-14-1711
• 09348215129064: 131-14-1709
• 09348215129057: 131-14-1705
• 09348215129040: 131-14-1513
• 09348215129033: 131-14-1511
• 09348215129026: 131-14-1509
• 09348215129019: 131-14-1505
• 09348215129002: 131-14-1013
• 09348215128999: 131-14-1011
• 09348215128982: 131-14-1009
• 09348215128975: 131-14-1005