Freedom Pedicle Screw System

GUDID 09348215030094

SIGNATURE ORTHOPAEDICS PTY LTD

Bone-screw internal spinal fixation system rod

• Primary Device ID: 09348215030094
• NIH Device Record Key: 94505c60-6bf5-4590-9897-fb62a83dcc2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freedom Pedicle Screw System
• Version Model Number: 131-13-5025
• 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	09348215030094 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-11-07
• Device Publish Date: 2019-01-17

On-Brand Devices [Freedom Pedicle Screw System]

• 09348215027049: 131-13-1540
• 09348215029777: 131-13-8800
• 09348215029760: 131-13-8890
• 09348215029753: 131-13-8880
• 09348215029746: 131-13-8870
• 09348215029739: 131-13-8860
• 09348215029722: 131-13-8855
• 09348215029715: 131-13-8850
• 09348215029708: 131-13-8845
• 09348215029692: 131-13-8840
• 09348215029685: 131-13-8835
• 09348215029678: 131-13-8700
• 09348215029661: 131-13-8790
• 09348215029654: 131-13-8780
• 09348215029647: 131-13-8770
• 09348215029630: 131-13-8760
• 09348215029623: 131-13-8755
• 09348215029616: 131-13-8750
• 09348215029609: 131-13-8745
• 09348215029593: 131-13-8740
• 09348215029586: 131-13-8735
• 09348215029579: 131-13-8660
• 09348215029562: 131-13-8655
• 09348215029555: 131-13-8650
• 09348215029548: 131-13-8645
• 09348215029531: 131-13-8640
• 09348215029524: 131-13-8635
• 09348215029517: 131-13-8550
• 09348215029500: 131-13-8545
• 09348215029494: 131-13-8540
• 09348215027162: 131-13-1750
• 09348215027155: 131-13-1745
• 09348215027148: 131-13-1740
• 09348215027131: 131-13-1735
• 09348215027124: 131-13-1660
• 09348215027117: 131-13-1655
• 09348215027100: 131-13-1650
• 09348215027094: 131-13-1645
• 09348215027087: 131-13-1640
• 09348215027070: 131-13-1635
• 09348215027063: 131-13-1550
• 09348215027056: 131-13-1545
• 09348215027032: 131-13-1535
• 09348215027025: 131-13-1530
• 09348215030537: 131-13-6269
• 09348215030520: 131-13-6257
• 09348215030513: 131-13-6245
• 09348215030506: 131-13-6239
• 09348215030490: 131-13-6234
• 09348215030483: 131-13-6230