Vietnam MOH registration 2402029ĐKLH/BYT-HTTB

Cervical Spinal Disc

VN: Đĩa đệm cột sống cổ

Vietnam·Risk Class TTBYT Loại C·ACTIV C IMPLANT FLAT·AESCULAP AG·Registered Aug 27, 2024

Registration details

Analysis ID: 2402029ĐKLH/BYT-HTTB
Submission ID: 17001624/ĐKLH-BYT-TB-CT
Product Type: ACTIV C IMPLANT FLAT
Product Code: Theo phụ lục

Company information

Manufacturer: AESCULAP AG
Manufacturer Country: Theo theo phụ lục
Product Owner: AESCULAP AG
Authorized Representative: CÔNG TY TNHH B. BRAUN VIỆT NAM

Technical details

Intended Use: The Activ C cervical disc prosthesis is used to replace the cervical intervertebral disc in the upper part of the spine (between C3 and C7). It helps to restore the height of the intervertebral disc and the mobility of the segment. The Activ C cervical disc prosthesis consists of three components: The upper artificial disc with hooks to attach to the vertebral body. The lower artificial disc with a central peg to attach to the vertebral body. The polyethylene cushion. The upper and lower artificial discs and the polyethylene cushion form a ball and socket joint. The polyethylene cushion is precisely positioned – fitting snugly into the lower artificial disc. The Activ C cervical disc prosthesis is available in six different sizes (XS, S, M, L, XL and XXL) and two different heights (5 mm and 6 mm). The Activ C cervical disc prosthesis is supplied as a fully assembled unit.

Dates and status

Registration Date: Aug 27, 2024

About this record

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 2402029ĐKLH/BYT-HTTB and manufactured by AESCULAP AG. The authorized representative in Vietnam is CÔNG TY TNHH B. BRAUN VIỆT NAM.

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