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Arthrex PEEK Knotless SwiveLock® Suture Anchors - HSA Registration DE0505441

Access comprehensive regulatory information for Arthrex PEEK Knotless SwiveLock® 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 DE0505441 and owned by Arthrex Inc.,. The device was registered on February 05, 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
DE0505441
Arthrex PEEK Knotless SwiveLock® Suture Anchors
HSA Registration Number: DE0505441
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Product Description

The Arthrex PEEK Knotless SwiveLock® Suture Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, 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, Illiotibial Band Tenodesis; Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar/Radial Collateral Ligament Reconstruction; Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair; Hip: Acetabular labral repair.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0505441
Registration Date
February 05, 2021
Retention Due Date
February 04, 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)
PEEK Knotless SwiveLock® Suture Anchor, 5.5 x 19.1mm PEEK Knotless SwiveLock® Suture Anchor, 5.5 x 19.1mm PEEK Knotless SwiveLock® Suture Anchor, 4.75 x 19.1mm PEEK Knotless SwiveLock® Suture Anchor, 4.75 x 19.1mm PEEK Knotless SwiveLock® Suture Anchor, 4.75 x 19.1mm PEEK Knotless SwiveLock® Suture Anchor, 4.75 x 19.1mm PEEK Knotless SwiveLock® Suture Anchor, 4.75 x 19.1mm PEEK Knotless SwiveLock® Suture Anchor, 4.75 x 19.1mm
Model Identifier(s)
AR-2323KPSLC AR-2323KPSLC-1 AR-2324KPCT AR-2324KPCT-1 AR-2324KPCTT AR-2324KPCTT-1 AR-2324KPSLC AR-2324KPSLC-1