PMDA device listing

ATTUNE S+ RP 脛骨トレイ

PMDA Medical device listing · 23100BZX00010000 · Class III

Key facts

PMDA document key 340216_23100BZX00010000_A_01
Brand names ATTUNE S+ RP 脛骨トレイ
General names (JMDN) 人工膝関節脛骨コンポーネント
Product type Medical device
Device class (Japan) Class III
Approval, certification or notification number 23100BZX00010000
JMDN codes 35669000
Category code B0400
Marketing authorization holder 製造販売/ジョンソン・エンド・ジョンソン株式会社
Package insert date Aug 6, 2025
Latest revision 2025-05
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
  • Yes 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:

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