Vietnam MOH registration 240000564/PCBA-HN

Lumbar Disc Prosthetic Disk Set

VN: Bộ dụng cụ đĩa đệm cột sống lưng

Vietnam·Risk Class TTBYT Loại A·Theo theo phụ lục·AESCULAP AG·Registered Apr 09, 2024

Registration details

Analysis ID: 240000564/PCBA-HN
Submission ID: 000.00.19.H26-240403-0009
Product Type: Theo theo phụ lục
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 lumbar interbody fusion cage is used to introduce the TSPACE PEEK (third generation), TSPACE XP and TSPACE 3D test discs and to implant them into the lumbar spine. The SN305R disc placement rod is used to implant the bone graft components and to determine the size of the bone graft components by inserting the test disc rod into the interbody space. The SN320R tamper is attached to the delivery tool. The tamper is used to push the test discs out of the interbody space or to reposition the bone graft components. The SN304R bone cement base (for TSPACE PEEK (generation 3)/TSPACE XP) is used to hold the bone graft components on the operating table while the internal side door is filled with bone cement.

Dates and status

Registration Date: Apr 09, 2024

About this record

Access comprehensive regulatory information for Lumbar Disc Prosthetic Disk Set in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại A medical device is registered under number 240000564/PCBA-HN and manufactured by AESCULAP AG. The authorized representative in Vietnam is CÔNG TY TNHH B. BRAUN VIỆT NAM.

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