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Arthrex Disposable Kit for DX SwiveLock® - HSA Registration DE0506034

Access comprehensive regulatory information for Arthrex Disposable Kit for DX SwiveLock® in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506034 and owned by Arthrex Inc.,. The device was registered on August 02, 2021.

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.

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CLASS B
DE0506034
Arthrex Disposable Kit for DX SwiveLock®
HSA Registration Number: DE0506034
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Product Description

The Arthrex Disposable Kits for DX SwiveLock®, AR-8980DS is used for the implantation of DX SwiveLock Anchor, 4.75mm x 16mm (AR-8980P-1). The Arthrex Disposable Kits for DX SwiveLock®, AR-8980DS is intended for the fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, elbow, and hip. Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Capsular Shift, and Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-foot Reconstruction Elbow: Biceps Tendon Reattachment Hip: Acetabular labral repair

Device Classification
Device Class
CLASS B
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0506034
Registration Date
August 02, 2021
Retention Due Date
August 01, 2025
Product Owner
Short Name
Arthrex Inc.,
Address
1370 Creekside Boulevard, Naples, FL 34108-1945, USA, UNITED STATES
Registrant
Address
21 BIOPOLIS ROAD, NUCLEOS, #03-08, SINGAPORE 138567
Importer
Address
Nucleous 21 Biopolis Rd., #03-08, SINGAPORE 138567
Model Information
Model Name(s)
Disposable Kit for DX SwiveLock® , 4.75mm
Model Identifier(s)
AR-8980DS