Leksell Frame Adaptor

FDA UDI

Class II (US FDA UDI)

by Medtech Llc

Identity

Trade Name: LEKSELL FRAME ADAPTOR FDA UDI
Generic Name: Multi-purpose stereotactic surgery system FDA UDI
Device Name: "LEKSELL FRAME ADAPTOR instrument Rosa One 3.1 (brain application) Mechanical adaptor to connect the support arm to the leksell stereotactic frame, supplied with 8 mm hexagonal key" FDA UDI
Model / Reference: 174017-00 FDA UDI
Description: "LEKSELL FRAME ADAPTOR instrument Rosa One 3.1 (brain application) Mechanical adaptor to connect the support arm to the leksell stereotactic frame, supplied with 8 mm hexagonal key" FDA UDI

Identifiers

Catalog Number: ROSAS00348 FDA UDI
Primary DI / UDI-DI: 03760244032126 FDA UDI
FDA Product Code: 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 Unsafe FDA UDI

Category: Multi-purpose stereotactic surgery system

Leksell Frame Adaptor 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

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 ed6c08f9-5994-4c27-afe6-b3b73e8369dc 34 fields · synced May 30, 2026