HSA · registration DE0510471Arthrex FiberTak® Button Suture Anchors
- Registration number
- DE0510471
- Model name
- FiberTak® Button Implant System With FiberTak Button Implant, 2.6 mm Drill, Drill Guide, #2 FiberLoop® Suture with Straight Needle and Free Needle; FiberTak® Button With 2-0 FiberLink™ Shuttling Suture (Blue, White/Black); Drill Pin, FiberTak® Button, 2.6 mm
- Model identifier
- AR-3680; AR-3681; AR-3682
- Registration date
- March 17, 2025
- Risk class
- Class C
- Product owner
- Arthrex, Inc.
- Registrant / registration holder
- ARTHREX SINGAPORE, PTE. LTD.
The Arthrex FiberTak® Button Suture Anchors are intended to be used for suture or tissue fixation in the shoulder, foot/ankle, knee, hand/wrist, elbow and hip. The FiberTak button suture anchor is also used for fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow.
- Product owner address
- 1370 Creekside Boulevard, Naples, Florida, 34108-1945, United States
- Registrant address
- Nucleous 21 Biopolis Rd., #03-08, Singapore 138567
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.