Verteloc Lumbar Cage

GUDID 09348215129354

SIGNATURE ORTHOPAEDICS PTY LTD

Metallic spinal interbody fusion cage

• Primary Device ID: 09348215129354
• NIH Device Record Key: c68385f7-8d85-4dc9-8345-b1760cc82d7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Verteloc Lumbar Cage
• Version Model Number: 131-039-223
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09348215129354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172020

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

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: 2024-03-20
• Device Publish Date: 2024-03-12

On-Brand Devices [Verteloc Lumbar Cage ]

• 09348215129682: 131-037-927
• 09348215129675: 131-037-923
• 09348215129668: 131-037-827
• 09348215129651: 131-037-823
• 09348215129644: 131-037-727
• 09348215129637: 131-037-723
• 09348215129620: 131-037-327
• 09348215129613: 131-037-323
• 09348215129606: 131-037-227
• 09348215129590: 131-037-223
• 09348215129583: 131-037-127
• 09348215129576: 131-037-123
• 09348215129552: 131-037-023
• 09348215129545: 131-039-527
• 09348215129408: 131-031-127
• 09348215129392: 131-031-527
• 09348215129385: 131-031-327
• 09348215129378: 131-031-227
• 09348215129361: 131-039-323
• 09348215129354: 131-039-223
• 09348215129347: 131-039-123
• 09348215129330: 131-039-023
• 09348215129323: 131-039-923
• 09348215129316: 131-031-027
• 09348215129309: 131-031-927
• 09348215129293: 131-031-727
• 09348215129286: 131-039-327
• 09348215129279: 131-039-227
• 09348215129262: 131-039-127
• 09348215129255: 131-039-027
• 09348215129248: 131-039-927
• 09348215129231: 131-037-527
• 09348215129224: 131-039-727