Cervical Spinal Disc - Vietnam Registration 2400385ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Cervical Spinal Disc 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 2400385ĐKLH/BYT-HTTB and manufactured by CENTINEL SPINE, LLC. The authorized representative in Vietnam is CÔNG TY TNHH TRANSMEDIC HEALTHCARE.

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including SeaSpine Orthopedics Corporation, Novaspine S.A.S., and 5 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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2400385ĐKLH/BYT-HTTB

Registration Details

Vietnam MOH Registration: 2400385ĐKLH/BYT-HTTB

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Device Details

Cervical Spinal Disc

VN: Đĩa đệm cột sống cổ

Risk Class TTBYT Loại C

Registration Details

Analysis ID

2400385ĐKLH/BYT-HTTB

Submission ID

000.00.04.G18-220719-0014

Product Type

Theo theo phụ lục

Product Code

Theo phụ lục

Technical Details

Intended Use

The Prodisc C Vivo cervical disc prosthesis is used to replace the cervical intervertebral disc, restoring the height and motion of each segment of the spine. Cervical discogenic disease with symptoms (SCDD) is defined as cervical pain or radiating arm pain (neurogenic symptoms) and/or neurologic dysfunction with at least one of the following conditions confirmed by imaging (CT, MRI, or X-ray): •Herniated nucleus pulposus •Osteoarthritis of the vertebrae (determined by the presence of bone spurs) •Loss of disc height