Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014507028

FEI Number

3014507028

Entity Name

FMI LLC

City/State/Country

Lincolnshire, IL, US

Establishment Address

500 Bond Street, Lincolnshire, IL 60069, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

FMI LLC (Owner Number: 10052883)

Owner / Operator Contact Address

500 Bond Street, Lincolnshire, IL 60069, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SPLINT 1524055 DOYLE II AIRWAY SET, SPLINT 1524050 5PK DOYLE II AIRWAY Precision Suture Sleeve Fixation Tab

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2016-10-14
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2023-09-19
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2019-04-11

Official Correspondent

Sommer Altvater

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FMI LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007285848	FLEXAN (SUZHOU) PRECISION RUBBER PRODUCTS CO., LTD.	Suzhou Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K981246	Integra Neurocare, LLC	BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)	1999-05-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2018	St. Jude Medical, Inc.	3	Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
Z-0024-2018	St. Jude Medical, Inc.	3	Proclaim DRG Implantable Pulse Generator Model 3664
Z-0025-2013	Advanced Neuromodulation Systems Inc.	3	The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Z-0458-2026	Abbott Medical	3	Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Z-2358-2024	Abbott Medical	3	Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014507028. Last updated year: 2026. Please use registration number 3014507028 when referencing this establishment in official correspondence.