Aquila Anterior Cervical Plate Screw

GUDID 09348215125967

SIGNATURE ORTHOPAEDICS PTY LTD

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 09348215125967
• NIH Device Record Key: a90cf8db-bd54-44be-81f2-0bed830dea55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aquila Anterior Cervical Plate Screw
• Version Model Number: 131-16-6212
• 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	09348215125967 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181190

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-12
• Device Publish Date: 2024-02-02

On-Brand Devices [Aquila Anterior Cervical Plate Screw]

• 09348215126315: 131-16-8520
• 09348215126308: 131-16-8518
• 09348215126292: 131-16-8516
• 09348215126285: 131-16-8514
• 09348215126278: 131-16-8512
• 09348215126261: 131-16-8420
• 09348215126254: 131-16-8418
• 09348215126247: 131-16-8416
• 09348215126230: 131-16-8414
• 09348215126223: 131-16-8412
• 09348215126216: 131-16-8320
• 09348215126209: 131-16-8318
• 09348215126193: 131-16-8316
• 09348215126186: 131-16-8314
• 09348215126179: 131-16-8312
• 09348215126162: 131-16-8220
• 09348215126155: 131-16-8218
• 09348215126148: 131-16-8216
• 09348215126131: 131-16-8214
• 09348215126124: 131-16-8212
• 09348215126056: 131-16-6320
• 09348215126049: 131-16-6318
• 09348215126032: 131-16-6316
• 09348215126025: 131-16-6314
• 09348215126018: 131-16-6312
• 09348215126001: 131-16-6220
• 09348215125998: 131-16-6218
• 09348215125981: 131-16-6216
• 09348215125974: 131-16-6214
• 09348215125967: 131-16-6212