QuadLock™ Fixation System 11mm

GUDID 28437019739762

The QuadLock™ Fixation System is intended for fixation of suture/tape (soft tissue) to bone.

ABANZA TECNOMED SL.

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 28437019739762
• NIH Device Record Key: f6b04969-937f-479e-a9da-835fc9acadd0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuadLock™ Fixation System 11mm
• Version Model Number: NA
• Company DUNS: 465714287
• Company Name: ABANZA TECNOMED SL.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437019739768 [Primary]
GS1	28437019739762 [Package]; Contains: 08437019739768; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K253618

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-22
• Device Publish Date: 2026-01-14

Devices Manufactured by ABANZA TECNOMED SL.

• 28437019739748 - QuadLock™ Fixation System 9mm: 2026-01-22 The QuadLock™ Fixation System is intended for fixation of suture/tape (soft tissue) to bone.
• 28437019739755 - QuadLock™ Fixation System 10mm: 2026-01-22 The QuadLock™ Fixation System is intended for fixation of suture/tape (soft tissue) to bone.
• 28437019739762 - QuadLock™ Fixation System 11mm: 2026-01-22The QuadLock™ Fixation System is intended for fixation of suture/tape (soft tissue) to bone.
• 28437019739762 - QuadLock™ Fixation System 11mm: 2026-01-22 The QuadLock™ Fixation System is intended for fixation of suture/tape (soft tissue) to bone.
• 28437019739861 - WasherCap™ Fixation System 11mm: 2025-03-18 WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue
• 28437019739892 - WasherCap Mini Fixation system 3.5mm: 2025-03-05 The WasherCap™ Mini Fixation System is a medical device designed for fixation of suture/tape (soft tissue) to bone during surg
• 28437019739908 - WasherCap Mini Fixation system 4.5mm: 2025-03-05 The WasherCap™ Mini Fixation System is a medical device designed for fixation of suture/tape (soft tissue) to bone during surg
• 08437019739812 - WasherCap™ Fixation System 7mm: 2023-06-19 WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue
• 08437019739829 - WasherCap™ Fixation System 8mm: 2023-06-19 WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue