Adante AX Orthopedic Surgical Platform

FDA UDI

Class I (US FDA UDI)

by Mizuho Orthopedic Systems, Inc.

Identity

Trade Name: Adante AX Orthopedic Surgical Platform FDA UDI
Generic Name: Orthopaedic operating table, electromechanical FDA UDI
Model / Reference: 6895AX-00 FDA UDI

Identifiers

Catalog Number: 6895AX-00 FDA UDI
Primary DI / UDI-DI: 00842430117121 FDA UDI
FDA Product Code: JEA FDA UDI
GMDN Term: Orthopaedic operating table, electromechanical FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4960 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthopaedic operating table, electromechanical

Adante AX Orthopedic Surgical Platform by Mizuho Orthopedic Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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ADVANCED TABLE, OPERATING-ROOM, ELECTRICAL — ADVANCED INSTRUMENTATIONS, INC. · Class I
TABLE, ProFx, REFURBISHED — Mizuho Orthopedic Systems, Inc. · Class I
ASSY, BASE & TABLE TOP, ProFx INTL — Mizuho Orthopedic Systems, Inc. · Class I
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ASSY, BASE & TOP, ProFx — Mizuho Orthopedic Systems, Inc. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Mizuho Orthopedic Systems, Inc.

Sources (1)

FDA UDI 29230892-1833-4569-b3cd-265b3bb85958 35 fields · synced Jun 9, 2026