Vietnam MOH registration 2403327ĐKLH/BYT-HTTB

Vít neo used in arthroscopic surgery

VN: Vít neo dùng trong phẫu thuật nội soi khớp

Vietnam·Risk Class TTBYT Loại C·Fixone·Aju Pharm Co., Ltd.·Registered Nov 06, 2024

Registration details

Analysis ID: 2403327ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230407-0017
Product Type: Fixone
Product Code: Theo phụ lục

Company information

Manufacturer: Aju Pharm Co., Ltd.
Manufacturer Country: Theo theo phụ lục
Product Owner: Aju Pharm Co., Ltd.
Authorized Representative: CÔNG TY CỔ PHẦN ĐẦU TƯ TUẤN NGỌC MINH

Technical details

Intended Use: 1. Absorbable Screw for Arthroscopic Surgery of the Shoulder and Hybrid Screw for Arthroscopic Surgery of the Shoulder: The product is designed to fix the soft tissue (tendon) to the bone in shoulder arthroscopic surgery: -Shoulder: Repair of the labrum, Bankart repair, SLAP tear repair, Cutting the biceps tendon, Acromioclavicular separation repair, Delta muscle repair, Repair of the bursa or reconstruction of the joint capsule; -Ankle/ Tibia: Lateral stabilization, Midstance stabilization, Achilles tendon repair; -Knee: Repair of the medial collateral ligament, Repair of the lateral collateral ligament, Repair of the posterior cruciate ligament, Cutting the ligament bundle; -Elbow: Repair of the biceps tendon, Reconstruction of the Ulnar collateral ligament or the central collateral ligament. 2. Absorbable Screw Completely Made of Sutures for Arthroscopic Surgery of the Shoulder: The product is used to reattach the soft tissue (such as ligaments, tendons, joint capsule) to the bone; to fix the sutures and stabilize the damaged soft tissue in orthopedic, arthroscopic, or open surgery. 3. Absorbable Screw for Arthroscopic Repair of the Chondral Surface: It is used to repair the chondral surface defect

Dates and status

Registration Date: Nov 06, 2024

About this record

Access comprehensive regulatory information for Vít neo used in arthroscopic surgery 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 2403327ĐKLH/BYT-HTTB and manufactured by Aju Pharm Co., Ltd.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN ĐẦU TƯ TUẤN NGỌC MINH.

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