Vietnam MOH registration 2402955ĐKLH/BYT-HTTB

Fixed Ligament Screw Assembly

VN: Bộ vít cố định gân, dây chằng

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Signature Orthopaedics Europe Limited·Registered Oct 31, 2024

Registration details

Analysis ID: 2402955ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-231026-0010
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Signature Orthopaedics Europe Limited
Manufacturer Country: Theo theo phụ lục
Product Owner: Signature Orthopaedics Europe Limited
Authorized Representative: CÔNG TY CỔ PHẦN ĐẦU TƯ TUẤN NGỌC MINH

Technical details

Intended Use: 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

Registration Date: Oct 31, 2024

About this record

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.

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