NAMBUCCA Anterior Lumbar Plate

GUDID 09348215019785

SIGNATURE ORTHOPAEDICS PTY LTD

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 09348215019785
• NIH Device Record Key: b65e9909-86af-4cf6-bf00-e09b3cdf1cbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NAMBUCCA Anterior Lumbar Plate
• Version Model Number: PS1-10-0127
• 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	09348215019785 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163625

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-18
• Device Publish Date: 2017-08-25

On-Brand Devices [NAMBUCCA Anterior Lumbar Plate]

• 09348215019785: PS1-10-0127
• 09348215019778: PS1-10-0125
• 09348215019761: PS1-10-0123
• 09348215019754: PS1-10-0121
• 09348215019747: PS1-10-0119
• 09348215019730: PS1-10-0117