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Singapore HSA registration DE0510471

Arthrex FiberTak® Button Suture Anchors

Singapore flagSingapore·CLASS C·Arthrex, Inc.·Registered March 17, 2025
Device classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration information
Registration Number
DE0510471
Registration Date
March 17, 2025
Retention Due Date
March 16, 2026
Product description
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
Name
Arthrex, Inc.
Short Name
Arthrex, Inc.
Address
1370 Creekside Boulevard, Naples, Florida, 34108-1945, UNITED STATES
Registrant
Name
ARTHREX SINGAPORE, PTE. LTD.
Address
21 BIOPOLIS ROAD, NUCLEOS, #03-08, SINGAPORE 138567
Importer
Name
ARTHREX SINGAPORE PTE LTD
Address
Nucleous 21 Biopolis Rd., #03-08, SINGAPORE 138567
Model information
Model Name(s)
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(s)
AR-3680 AR-3681 AR-3682
About this record

Access comprehensive regulatory information for Arthrex FiberTak® Button Suture Anchors in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510471 and owned by Arthrex, Inc.. The device was registered on March 17, 2025.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C