Fastlok 8mm x 23mm n/a

GUDID 05060267134332

XIROS LTD

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 05060267134332
• NIH Device Record Key: 4d4b09c5-45b4-4dc3-ac56-e452e7e2e62e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fastlok 8mm x 23mm
• Version Model Number: 102-1381
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060267134332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K913461

FDA Product Code

• JDR: Staple, Fixation, Bone

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: 2025-04-04
• Device Publish Date: 2025-03-27

Devices Manufactured by XIROS LTD

• 05060267134325 - Fastlok 6mm X 23mm: 2025-04-04
• 05060267134332 - Fastlok 8mm x 23mm: 2025-04-04
• 05060267134332 - Fastlok 8mm x 23mm: 2025-04-04
• 05060267134301 - AchilloCordPLUS: 2025-04-03
• 05060267134349 - Rigid Probe: 2025-04-03
• 05060267134295 - Poly-Tape 5 mm x 500 mm: 2024-10-18
• 05060267134011 - CC-Hook Left: 2024-05-03
• 05060267134028 - CC-Hook Right: 2024-05-03
• 05060267133755 - Pitch-Patch: 2023-10-13 Tissue Reinforcement Device