Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016778562

FEI Number

3016778562

Entity Name

LINCOTEK BOLOGNA S.R.L.

City/State/Country

Cadriano di Granarolo, Bologna, IT

Establishment Address

via Bruno Buozzi 13 15, Cadriano di Granarolo, Bologna 40057, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Lincotek Bologna s.r.l. (Owner Number: 10093624)

Owner / Operator Contact Address

via Bruno Buozzi 13 15, Cadriano di Granarolo, Bologna, IT-BO 40057, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FFX Facet Fixation System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2025-12-04

Official Correspondent

Marco Rizzotti

US Agent Details

Domenico Grieco Business: Surface Dynamics, LLC d/b/a Lincotek Medical Email: Domenico.Grieco@lincotek.com Phone: (901) 3053132

Related Public Records

Same Entity

Lincotek Bologna s.r.l.

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
K173198	U&I Corporation	Facet Screw Fixation System	2018-01-03
K121850	Choicespine, LP	Typhoon(TM) Facet Screw Fixation System	2012-09-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2012	Osteomed, Lp 3885 Arapaho Rd Addison TX 75001	U	OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001

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3016443334	SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED	KADI Gujarat, IN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016778562. Last updated year: 2026. Please use registration number 3016778562 when referencing this establishment in official correspondence.