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Arthrex InternalBrace™ Implant System, Ligament Augmentation Repair, PEEK - HSA Registration DE0505890

Access comprehensive regulatory information for Arthrex InternalBrace™ Implant System, Ligament Augmentation Repair, PEEK in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505890 and owned by Arthrex Inc.,. The device was registered on June 16, 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
DE0505890
Arthrex InternalBrace™ Implant System, Ligament Augmentation Repair, PEEK
HSA Registration Number: DE0505890
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Product Description

The Arthrex SwiveLock suture anchors are intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip for the following indications: 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, Hallux Valgus Reconstruction, Metatarsal Ligament Repair, 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
DE0505890
Registration Date
June 16, 2021
Retention Due Date
June 15, 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)
InternalBrace™ Implant System, Ligament Augmentation Repair, PEEK
Model Identifier(s)
AR-1778P-CP