Advantage ALIF Trial Cage

GUDID 09348215067960

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215067960
• NIH Device Record Key: 46257a6e-cf34-4aa5-a098-2b7b7a9ca89b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advantage ALIF Trial Cage
• Version Model Number: 132-23-3121
• 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	09348215067960 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172019

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[09348215067960]

Moist Heat or Steam Sterilization

[09348215067960]

Moist Heat or Steam Sterilization

[09348215067960]

Moist Heat or Steam Sterilization

[09348215067960]

Moist Heat or Steam Sterilization

[09348215067960]

Moist Heat or Steam Sterilization

[09348215067960]

Moist Heat or Steam Sterilization

[09348215067960]

Moist Heat or Steam Sterilization

[09348215067960]

Moist Heat or Steam Sterilization

[09348215067960]

Moist Heat or Steam Sterilization

[09348215067960]

Moist Heat or Steam Sterilization

[09348215067960]

Moist Heat or Steam Sterilization

[09348215067960]

Moist Heat or Steam Sterilization

[09348215067960]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-09
• Device Publish Date: 2020-07-01

On-Brand Devices [Advantage ALIF Trial Cage]

• 09348215068271: 132-23-5167
• 09348215068264: 132-23-5165
• 09348215068257: 132-23-5163
• 09348215068240: 132-23-5161
• 09348215068233: 132-23-5127
• 09348215068226: 132-23-5125
• 09348215068219: 132-23-5123
• 09348215068202: 132-23-5121
• 09348215068196: 132-23-5087
• 09348215068189: 132-23-5085
• 09348215068172: 132-23-5083
• 09348215068165: 132-23-5081
• 09348215068158: 132-23-4167
• 09348215068141: 132-23-4165
• 09348215068134: 132-23-4163
• 09348215068127: 132-23-4161
• 09348215068110: 132-23-4127
• 09348215068103: 132-23-4125
• 09348215068097: 132-23-4123
• 09348215068080: 132-23-4121
• 09348215068073: 132-23-4087
• 09348215068066: 132-23-4085
• 09348215068059: 132-23-4083
• 09348215068042: 132-23-4081
• 09348215068035: 132-23-3167
• 09348215068028: 132-23-3165
• 09348215068011: 132-23-3163
• 09348215068004: 132-23-3161
• 09348215067991: 132-23-3127
• 09348215067984: 132-23-3125
• 09348215067977: 132-23-3123
• 09348215067960: 132-23-3121
• 09348215067953: 132-23-3087
• 09348215067946: 132-23-3085
• 09348215067939: 132-23-3083
• 09348215067922: 132-23-3081