PMDA device listing

トランスフィックス スクリュー

PMDA Medical device listing · 21300BZY00576000 · Class III

Key facts

PMDA document key 111882_21300BZY00576000_A_04
Brand names トランスフィックス スクリュー
General names (JMDN) 靱帯固定具
Product type Medical device
Device class (Japan) Class III
Approval, certification or notification number 21300BZY00576000
JMDN codes 36174003
Category code A5800
Marketing authorization holder 製造販売/ArthrexJapan合同会社
Package insert date Feb 16, 2022
PMDA product page pmda.go.jp
Package insert on pmda.go.jp pmda.go.jp

At a glance

  • 1–9 Package insert revisions
  • None Related PMDA documents
  • Listed Listed on the PMDA site
  • No Refers to a technical manual

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMDA medical device and IVD listings (Japan)

Medical devices and in vitro diagnostics sold in Japan are approved by the MHLW, certified by a registered certification body or notified, depending on class, and the PMDA publishes each product's package insert. Only identifiers, names and dates are shown here; package insert text and review reports are not reproduced.

Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, medical device package insert database · Source date:

Browse all PMDA medical device and IVD listings (Japan)