PMDA device listing

四ツ目キリ

PMDA Medical device listing · 13B1X00306G00918 · Class I

Key facts

PMDA document key 750054_13B1X00306G00918_A_01
Brand names 四ツ目キリ
General names (JMDN) 骨ネジスタータ
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B1X00306G00918
JMDN codes 32859000
Category code A5800
Marketing authorization holder 製造販売/ミズホ株式会社
Package insert date Mar 22, 2018
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)