Aquila Anterior Cervical Plate System

GUDID 09348215125837

SIGNATURE ORTHOPAEDICS PTY LTD

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 09348215125837
• NIH Device Record Key: 7808d5cb-c44f-4668-9526-9507bfbd967e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aquila Anterior Cervical Plate System
• Version Model Number: 131-16-3051
• 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	09348215125837 [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 System]

• 09348215126117: 131-16-5105
• 09348215126100: 131-16-5100
• 09348215126094: 131-16-5095
• 09348215126087: 131-16-5090
• 09348215126070: 131-16-5085
• 09348215126063: 131-16-5080
• 09348215125950: 131-16-4088
• 09348215125943: 131-16-4084
• 09348215125936: 131-16-4080
• 09348215125929: 131-16-4076
• 09348215125912: 131-16-4072
• 09348215125905: 131-16-4068
• 09348215125899: 131-16-4064
• 09348215125882: 131-16-3066
• 09348215125875: 131-16-3063
• 09348215125868: 131-16-3060
• 09348215125851: 131-16-3057
• 09348215125844: 131-16-3054
• 09348215125837: 131-16-3051
• 09348215125820: 131-16-3048
• 09348215125813: 131-16-3045
• 09348215125806: 131-16-3042
• 09348215125790: 131-16-2044
• 09348215125783: 131-16-2042
• 09348215125776: 131-16-2040
• 09348215125769: 131-16-2038
• 09348215125752: 131-16-2036
• 09348215125745: 131-16-2034
• 09348215125738: 131-16-2032
• 09348215125721: 131-16-2030
• 09348215125714: 131-16-1030
• 09348215125707: 131-16-1028
• 09348215125691: 131-16-1026
• 09348215125684: 131-16-1024
• 09348215125677: 131-16-1022
• 09348215125660: 131-16-1020
• 09348215125653: 131-16-1018
• 09348215125646: 131-16-1016
• 09348215125639: 131-16-1014
• 09348215125622: 131-16-1012