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Arthrex PEEK Knotless Corkscrew® Suture Anchor - HSA Registration DE0505383

Access comprehensive regulatory information for Arthrex PEEK Knotless Corkscrew® Suture Anchor in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505383 and owned by Arthrex Inc.,. The device was registered on January 25, 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 C
DE0505383
Arthrex PEEK Knotless Corkscrew® Suture Anchor
HSA Registration Number: DE0505383
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Product Description

The Arthrex Corkscrew is intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Midfoot Reconstruction, Hallux Valgus Reconstruction, Metatarsal Ligament Repair and Metatarsal Tendon Repair Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair and Illiotibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment, Ulnar/Radial collateral Ligament Reconstruction and Lateral Epicondylitis Repair. Hip: Acetabular labral repair.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0505383
Registration Date
January 25, 2021
Retention Due Date
January 24, 2026
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)
Drill, 3.9mm Knotless Corkscrew® Disposable Instrument Kit for 3.9mm Knotless Corkscrew® PEEK Knotless Corkscrew® Suture Anchor PEEK, 3.9mm Knotless Corkscrew®
Model Identifier(s)
AR-1941D AR-1941DS AR-1941PS AR-1941PSV