Vietnam MOH registration 2401077ĐKLH/BYT-HTTB

Fixed tendon, ligament

VN: Vít cố định gân, dây chằng

BIOTEK, SOFTFIX-PK®, SOFTFIX®

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Chetan Meditech Pvt. Ltd.·Registered Jul 21, 2024

Registration details

Analysis ID: 2401077ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230823-0005
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Chetan Meditech Pvt. Ltd.
Manufacturer Country: Theo theo phụ lục
Product Owner: Chetan Meditech Pvt. Ltd.
Authorized Representative: CÔNG TY TNHH ANDAMAN MEDICAL VIỆT NAM

Technical details

Intended Use: Purpose of Use These devices are intended to be used to fix soft tissue to bone, including tendons or ligaments to bone, or bone to bone. The device is also used for reattachment of soft tissue (e.g., fixation of tendon and ligament grafts). The device may be used in both open and arthroscopic surgery. Indications for Use Specific indications: Knee: Anterior Cruciate Ligament (ACL) injury, Posterior Cruciate Ligament (PCL) injury (Repair/Reconstruction), Reconstruction of the long head of the biceps tendon, Improvement of the vastus medialis oblique (VMO), Posterior Cruciate Ligament (PCL) injury, Repair/Reconstruction of the medial collateral ligament (MCL) and lateral collateral ligament (LCL), Repair/Reconstruction of the torn patellar tendon (Patellar tendon or quadriceps tendon), Instability of the patella - Repair/Reconstruction of the patellar ligament (MPFL) (Trade names: BIOTEK, SOFTFIX, SOFTFIX-PK) Ankle/Forefoot: Lateral stabilization, Midfoot stabilization, Reconstruction of the Achilles tendon, Reconstruction of the midfoot and forefoot, Repair of the ligaments/tendons of the foot, Transfer of the toe tendons, Reconstruction of the navicular bone, Reconstruction of the deltoid muscle (Trade names: BIOTEK, SOFTFIX, SOFTFIX-PK) Elbow: Allograft of the biceps tendon, Reconstruction of the lateral collateral ligament/medial collateral ligament, Treatment of lateral epicondylitis/tennis elbow (Trade names: BIOTEK, SOFTFIX, SOFTFIX-PK) Shoulder: Repair of the labrum, Biceps tendon surgery (Trade names: BIOTEK, SOFTFIX-PK), Treatment of shoulder instability (Trade names: BIOTEK BIO LATARJET, LCSLATARJET) The surgeon must use his professional judgment to determine the appropriate screw size based on the specific indication, preferred surgical technique, and patient history.

Dates and status

Registration Date: Jul 21, 2024

About this record

Access comprehensive regulatory information for Fixed tendon, ligament 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 2401077ĐKLH/BYT-HTTB and manufactured by Chetan Meditech Pvt. Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH ANDAMAN MEDICAL VIỆT NAM.

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