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Fixed Ligament Screw Assembly - Vietnam Registration 2402955ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Fixed Ligament Screw Assembly in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2402955ĐKLH/BYT-HTTB and manufactured by Signature Orthopaedics Europe Limited. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN ĐẦU TƯ TUẤN NGỌC MINH.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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2402955ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2402955ĐKLH/BYT-HTTB
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Device Details

Fixed Ligament Screw Assembly
VN: Bộ vít cố định gân, dây chằng
Risk Class TTBYT Loại C

Registration Details

2402955ĐKLH/BYT-HTTB

000.00.04.G18-231026-0010

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

Signature Orthopaedics Europe Limited

Technical Details

The bone anchor fixation device is indicated for the fixation of soft tissue, including ligaments or tendons to bone, where the size of the anchor is appropriate for the patient in the following cases: - Knee: Anterior cruciate ligament (ACL) repair, posterior cruciate ligament (PCL) repair, lateral collateral ligament (LCL) repair, repair of the outer sleeve of the ACL, PCL, LCL, bone realignment, and biceps tendon repair - Ankle & Foot: Repair/reconstruction of the instability on the inside of the ankle joint; Tendon transfer; Repair/reconstruction of the ligaments/tendons of the foot; Surgery for the removal of the big toe; Repair/reconstruction of the Achilles tendon, the tibialis posterior longus (FHL) muscle; Reconstruction of the midfoot - Shoulder: Capsular stabilization; Repair of the labrum and the labral tear; Anterior shoulder instability; Repair of the SLAP tear, cases of spontaneous dislocation or reconstruction of the labrum; Repair of the delta muscle; Tendon rupture of the biceps; Repair of the rotator cuff tear; … - Elbow, wrist, and hand: Repair of the biceps tendon; Reconstruction of the ulnar collateral ligament or the ulnar collateral ligament; Repair of the lateral epicondylitis; Reconstruction of the scapholunate ligament; Tendon transfer; Reconstruction of the wrist ligaments…

Dates and Status

Oct 31, 2024