Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009539885

FEI Number

3009539885

Entity Name

FABTECH PRECISION SHEET METAL, LLC

City/State/Country

Spokane Valley, WA, US

Establishment Address

16124 E Euclid, Spokane Valley, WA 99216, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Fabtech Precision Sheet Metal, LLC (Owner Number: 10042419)

Owner / Operator Contact Address

16124 E Euclid, Spokane Valley, WA 99216, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dental Cassette Dental Cassette Dental Cassette Dental Cassette

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2019-04-02
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-07-18
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2016-10-19
OFX	General Purpose Dental Tray	Dental	Class 1	872.6640	2016-04-05
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2012-11-26
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2015-07-07

Official Correspondent

Adam Cesal

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Fabtech Precision Sheet Metal, LLC

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
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20
K243425	Talladium España, SL	Guided DAS Surgical Kit	2025-07-22
K213209	K1 Medical, LLC	EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device	2021-12-28
K012105	Symmetry Medical, Inc.	POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM	2002-08-02
K243317	Infinitum Eta, Ltd.	NUVENTUS NV.C Surgical Cassette and Tray	2025-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0001-2018	Carl Zeiss Meditec AG Rudolf-Eber-Str. 11 Oberkochen Germany	2	Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments

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3010363540	JIANGYIN CITY RUIRUN CLOTHING CO., LTD.	Jiangyin City Jiangsu, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009539885. Last updated year: 2026. Please use registration number 3009539885 when referencing this establishment in official correspondence.