Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020983478

FEI Number

3020983478

Entity Name

ORTHOKEY ITALIA SRL

City/State/Country

Firenze, IT

Establishment Address

Piazza Puccini 26, Firenze 50144, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Orthokey Italia srl (Owner Number: 10083422)

Owner / Operator Contact Address

Piazza Puccini 26, Firenze, IT-FI 50144, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192653

PMA Number

N/A

All Registered Proprietary Names

PERSEUS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-11-18

Official Correspondent

Cristiano Paggetti

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

Orthokey Italia srl

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

Similar Registrations

Registration Number	Establishment Name	Location
3002743211	NORTHERN DIGITAL, INC.	WATERLOO Ontario, CA
3016050940	Olive Branch Distribution Center	Olive Branch, MS, US
3014725904	Medtronic Medical Costa Rica S.R.L.	Coyol Alajuela, CR
3018405359	A7 INTEGRATION	Granby Quebec, CA
3010232390	QUINTENZ HYBRIDTECHNIK GMBH	Neuried Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020983478. Last updated year: 2026. Please use registration number 3020983478 when referencing this establishment in official correspondence.