Robot Rosa One (usa)

FDA UDI

Class II (US FDA UDI)

by Medtech Llc

Identity

Trade Name: ROBOT ROSA ONE (USA) FDA UDI
Generic Name: Multi-purpose stereotactic surgery system FDA UDI
Device Name: "Standard ROSA® ONE Surgical Assistant device( including robot arm and stand , touch screen, support arm) 120 V - 60 Hz - Plug B" FDA UDI
Model / Reference: 3.1.4.0 FDA UDI
Description: "Standard ROSA® ONE Surgical Assistant device( including robot arm and stand , touch screen, support arm) 120 V - 60 Hz - Plug B" FDA UDI

Identifiers

Catalog Number: ROSAS00203 FDA UDI
Primary DI / UDI-DI: 03760244033765 FDA UDI
510(k) Number: K192173 FDA UDI
K200511 FDA UDI
FDA Product Code: OLO FDA UDI
HAW FDA UDI
GMDN Term: Multi-purpose stereotactic surgery system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 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

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Multi-purpose stereotactic surgery system

Robot Rosa One (usa) by Medtech Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-purpose stereotactic surgery system.

TRIALTIS Spine System — MEDOS INTERNATIONAL SARL · Class IIa
Mo¨ller® — MEDTRONIC NAVIGATION, INC. · Class II
StealthStation® S7® — MEDTRONIC NAVIGATION, INC. · Class II
NIM-Spine — MEDTRONIC SOFAMOR DANEK, INC. · Class II
UNIVERSAL NAVIGATION VIPER SYSTEM — MEDOS INTERNATIONAL SARL · Class IIa
NAVIGATION ENABLED INSTRUMENTS — MEDOS INTERNATIONAL SARL · Class IIa
Stealth Autoguide™ System — MEDTRONIC NAVIGATION, INC. · Class II
Stealth Station® S7™ — MEDTRONIC NAVIGATION, INC. · Class II

Cleared under the same submission

K192173 also covers:

ROBOT ROSA ONE (USA) — MEDTECH LLC

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: Medtech Llc

Sources (1)

FDA UDI cd996bed-bb47-4765-be78-26d47239fa75 35 fields · synced May 31, 2026