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Singapore HSA registration DE0509845

Arthrex Nano SwiveLock® Suture Anchor with Fork Eyelet

Singapore flagSingapore·CLASS C·Arthrex, Inc.·Registered September 26, 2024
Device classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration information
Registration Number
DE0509845
Registration Date
September 26, 2024
Retention Due Date
September 25, 2025
Product description
The Arthrex Nano SwiveLock® Suture Anchor is intended to be used for suture (soft tissue) fixation to bone in the hand and wrist in adult patients. • Hand/Wrist: Scapholunate ligament reconstruction and ulnar/radial collateral ligament reconstruction, digital tendon transfers, carpometacarpal joint arthroplasty (basal thumb joint arthroplasty). Excluding skeletally mature pediatric patients.
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)
Disposable Kit, Nano SwiveLock®, 2.5 x 7 mm, with 2.0 mm Cannulated Drill, 2.2 mm Cannulated Drill, .86 mm Guidewires and Drill Guide Disposable Kit, Nano SwiveLock®, 2.5 x 7 mm, with 2.0 mm Cannulated Drill, 2.2 mm Cannulated Drill, .86 mm Guidewires and Drill Guide Nano SwiveLock® Suture Anchor with Fork Eyelet, 2.5 x 7 mm Nano SwiveLock® Suture Anchor with Fork Eyelet, 2.5 x 7 mm
Model Identifier(s)
AR-8998DS AR-8998DS-1 AR-8998T AR-8998T-1
About this record

Access comprehensive regulatory information for Arthrex Nano SwiveLock® Suture Anchor with Fork Eyelet in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509845 and owned by Arthrex, Inc.. The device was registered on September 26, 2024.

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