Vietnam MOH registration 2403350ĐKLH/BYT-HTTB

Pre-assembled vitreous retention pin

VN: Vít chỉ neo lắp sẵn

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Smith & Nephew Inc., Endoscopy·Registered Nov 06, 2024

Registration details

Analysis ID: 2403350ĐKLH/BYT-HTTB
Submission ID: 17004983/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Smith & Nephew Inc., Endoscopy
Manufacturer Country: Theo theo phụ lục
Product Owner: Smith & Nephew Inc., Endoscopy
Authorized Representative: VĂN PHÒNG ĐẠI DIỆN SMITH & NEPHEW ASIA PACIFIC PTE. LIMITED TẠI THÀNH PHỐ HỒ CHÍ MINH

Technical details

Intended Use: The TWINFIX Ti, a pre-attached vitallium screw, is used in a single procedure to reattach soft tissue to bone in the following cases: 1. Shoulder - Treatment of Bankart lesion - Treatment of SLAP lesion - Treatment of rotator cuff tear - Shoulder arthroscopic repair or shoulder instability correction - Glenohumeral ligament fixation - Treatment of Delta muscle atrophy 2. Ankle and Achilles tendon - Ankle ligament reconstruction - Deep transverse Achilles tendon tear repair 3. Elbow, wrist, and hand - Lateral or medial collateral ligament reconstruction of the elbow - Repair of the biceps tendon origin 4. Knee - Treatment of extra-articular knee ligament injuries + Medial collateral ligament tear + Lateral collateral ligament tear + Anterior cruciate ligament tear - Femoral retinacular ligament fixation - Treatment of patellar tendonosis and patellar realignment: including the VMO advanced femoral tunnel technique

Dates and status

Registration Date: Nov 06, 2024

About this record

Access comprehensive regulatory information for Pre-assembled vitreous retention pin 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 2403350ĐKLH/BYT-HTTB and manufactured by Smith & Nephew Inc., Endoscopy. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN SMITH & NEPHEW ASIA PACIFIC PTE. LIMITED TẠI THÀNH PHỐ HỒ CHÍ MINH.

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