n/a n/a

GUDID 05060267131508

SECURE-LOOP 55MM

XIROS LTD

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 05060267131508
• NIH Device Record Key: 9401bb0d-7fe7-4ff4-b297-2a6c7b13b6aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: n/a
• Version Model Number: 102-4055
• Catalog Number: n/a
• Company DUNS: 228209805
• Company Name: XIROS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +4401132387202
• Email: enquiries@neoligaments.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: (508) 618-1337
• Email: enquiries@xirosna.com
• Phone: +441132387202
• Email: enquiries@xiros.co.uk
• Phone: +441132387202
• Email: enquiries@xiros.co.uk
• Phone: +441132387202
• Email: enquiries@xiros.co.uk
• Phone: +441132387202
• Email: enquiries@xiros.co.uk
• Phone: +441132387202
• Email: enquiries@xiros.co.uk
• Phone: +441132387202
• Email: enquiries@xiros.co.uk
• Phone: +441132387202
• Email: enquiries@xiros.co.uk
• Phone: +441132387202
• Email: enquiries@xiros.co.uk
• Phone: +441132387202
• Email: enquiries@xiros.co.uk
• Phone: +441132387202
• Email: enquiries@xiros.co.uk
• Phone: +441132387202
• Email: enquiries@xiros.co.uk
• Phone: +441132387202
• Email: enquiries@xiros.co.uk
• Phone: +441132387202
• Email: enquiries@xiros.co.uk
• Phone: +441132387202
• Email: enquiries@xiros.co.uk
• Phone: +441132387202
• Email: enquiries@xiros.co.uk
• Phone: +441132387202
• Email: enquiries@xiros.co.uk
• Phone: +441132387202
• Email: enquiries@xiros.co.uk

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060267131508 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151601

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-05-28

On-Brand Devices [n/a]

• 05060267131515: SECURE-LOOP 60MM
• 05060267131508: SECURE-LOOP 55MM
• 05060267131492: SECURE-LOOP 50MM
• 05060267131485: SECURE-LOOP 45MM
• 05060267131478: SECURE-LOOP 40MM
• 05060267131461: SECURE-LOOP 35MM
• 05060267131454: SECURE-LOOP 30MM
• 05060267131447: SECURE-LOOP 25MM
• 05060267131430: SECURE-LOOP 20MM
• 05060267131423: SECURE-LOOP 15MM
• 05060267131416: SECURE-LOOP 10MM
• 05060267130884: Sliding Hammer
• 05060267130785: Impactor Assembly
• 05060267130563: AchilloCordPLUS Poly-Tape
• 05060267130112: 8mm x 23mm Fastlok
• 05060267130099: 6mm x 23mm Fastlok
• 05060267131836: Infinity-Lock Button System
• 05060267131362: CC-Hook Right
• 05060267131355: CC-Hook Left