Centaur Pedicle Screw System

GUDID 09348215127374

SIGNATURE ORTHOPAEDICS PTY LTD

Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 09348215127374
• NIH Device Record Key: e8b2d7e8-85bf-454a-9ff6-6dd6e48bb3d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Centaur Pedicle Screw System
• Version Model Number: 131-08-5150
• 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	09348215127374 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180754

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

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 [Centaur Pedicle Screw System]

• 09348215127480: 131-08-6358
• 09348215127473: 131-08-6345
• 09348215127466: 131-08-6339
• 09348215127459: 131-08-6336
• 09348215127442: 131-08-6334
• 09348215127435: 131-08-6330
• 09348215127428: 131-08-6326
• 09348215127411: 131-08-5948
• 09348215127404: 131-08-5930
• 09348215127398: 131-08-5480
• 09348215127381: 131-08-5300
• 09348215127374: 131-08-5150
• 09348215127367: 131-08-5095
• 09348215127350: 131-08-5090
• 09348215127343: 131-08-5085
• 09348215127336: 131-08-5080
• 09348215127329: 131-08-5075
• 09348215127312: 131-08-5070
• 09348215127305: 131-08-5065
• 09348215127299: 131-08-5060
• 09348215127282: 131-08-5055
• 09348215127275: 131-08-5050
• 09348215127268: 131-08-5045
• 09348215127251: 131-08-5040
• 09348215127244: 131-08-5035
• 09348215127237: 131-08-5030
• 09348215127220: 131-08-4890
• 09348215127213: 131-08-4880
• 09348215127206: 131-08-4870
• 09348215127190: 131-08-4865
• 09348215127183: 131-08-4860
• 09348215127176: 131-08-4855
• 09348215127169: 131-08-4850
• 09348215127152: 131-08-4845
• 09348215127145: 131-08-4840
• 09348215127138: 131-08-4800
• 09348215127121: 131-08-2760
• 09348215127114: 131-08-2755
• 09348215127107: 131-08-2750
• 09348215127091: 131-08-2745
• 09348215127084: 131-08-2740
• 09348215127077: 131-08-2735
• 09348215127060: 131-08-2730
• 09348215127053: 131-08-2725
• 09348215127046: 131-08-2720
• 09348215127039: 131-08-2660
• 09348215127022: 131-08-2655
• 09348215127015: 131-08-2650
• 09348215127008: 131-08-2645
• 09348215126995: 131-08-2640