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.
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Device Details
Registration Details
2402955ĐKLH/BYT-HTTB
000.00.04.G18-231026-0010
Theo theo phụ lục
Theo phụ lục
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

