Midas Rex®

FDA UDI

Class II (US FDA UDI)

by Medtronic Powered Surgical Solutions

Identity

Trade Name: Midas Rex® FDA UDI
Generic Name: Manual bone mill FDA UDI
Device Name: CONSOLE BM120 ELECTRIC BONE MILL ROHS FDA UDI
Model / Reference: BM120 FDA UDI
Description: CONSOLE BM120 ELECTRIC BONE MILL ROHS FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169999176 FDA UDI
510(k) Number: K012453 FDA UDI
FDA Product Code: HBC FDA UDI
GMDN Term: Manual bone mill FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4360 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Manual bone mill

Midas Rex® by Medtronic Powered Surgical Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual bone mill.

Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
BONE MILL SET — SONTEC INSTRUMENTS, INC. · Class I
Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
BONE MILL — KLS-Martin L.P. · Class I
BONE GRINDER — SONTEC INSTRUMENTS, INC. · Class I
Milling Drum Extra Extra Coarse — Spierings Orthopaedics B.V. · Class I
Hu-Friedy — HU-FRIEDY MFG CO., LLC · Class I
SCHWERT — A. Schweickhardt GmbH & Co. KG · Class I

Cleared under the same submission

K012453 also covers:

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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Medtronic Powered Surgical Solutions

Sources (1)

FDA UDI e9d52634-5faa-4f77-98fa-2684f4034245 36 fields · synced Jun 9, 2026