Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043520095

FEI Number

3043520095

Entity Name

MR SURGICAL SOLUTIONS, LLC

City/State/Country

Zurich, CH

Establishment Address

Bubenbergstrasse 1, 3rd Floor, Zurich 8045, CH

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

MR Surgical Solutions, LLC (Owner Number: 10095076)

Owner / Operator Contact Address

Bubenbergstrasse 1, 3rd Floor, Zürich, CH-ZH 8045, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252530

PMA Number

N/A

All Registered Proprietary Names

OptiVu Shoulder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SBF	Orthopedic Augmented Reality	Neurology	Class 2	882.4560	2026-01-21

Official Correspondent

Brian Karpinski

US Agent Details

Stefanos Tsakiris Email: stefanos@fixsurgical.com Phone: (610) 7331839

Related Public Records

Same Entity

MR Surgical Solutions, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043520095. Last updated year: 2026. Please use registration number 3043520095 when referencing this establishment in official correspondence.