Device
The QuadLock™ Fixation System is intended for fixation of suture/tape (soft tissue) to bone.
Manufacturer
ABANZA TECNOMED SL.
ABANZA TECNOMED SL.
Model: NA
DI: 08437019739751
Status: Update
MRI: MR Safe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-01-14
Current Version: 2026-05-27
Description
The QuadLock™ Fixation System is intended for fixation of suture/tape (soft tissue) to bone.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
abb608d0-ff8f-4944-83ad-bd1e354ddc1a
Distribution Status:
In Commercial Distribution
DUNS Number:
465714287
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
28437019739755
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
1
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
08437019739751
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
08437019739751
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
28437022911209
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
2
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
28437019739755
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 45062
Name: Tendon/ligament bone anchor, non-bioabsorbable
Definition:
A non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].
FDA Product Codes
MBI
Fastener, Fixation, Nondegradable, Soft Tissue
Premarket Submissions
Submission Number:
K253618
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Type:
Special Storage Condition, Specify
Item #1 - Storage Handling Special Condition Text:
Keep dry
Item #2 - Storage Handling Type:
Special Storage Condition, Specify
Item #2 - Storage Handling Special Condition Text:
Keep away from sunlight