Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021119558

FEI Number

3021119558

Entity Name

Assembly-Tek LLC

City/State/Country

Dayton, OH, US

Establishment Address

295 S Alex Rd, Dayton, OH 45449, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Assembly-Tek / NCE (Owner Number: 10083684)

Owner / Operator Contact Address

295 S. Alex, West Carrollton, OH 45449, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K052567

PMA Number

N/A

All Registered Proprietary Names

EZ-TRAX OTK 210 One Tray Processing Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2024-07-23
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2021-12-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Assembly-Tek / NCE

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
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
K112536	Covidien	SONICISION STERILIZATION TRAY	2012-04-19

Similar Registrations

Registration Number	Establishment Name	Location
3014191428	TydenBrooks	Tallapoosa, GA, US
3008132392	Medicom Asia-Pacific Holdings Limited. Taiwan Branch	Wujie Township Yilan, TW
1526531	STERIS Corporation	CLEVELAND, OH, US
3005706667	TURNER MEDICAL INC.	Athens, AL, US
3008719017	SUMMIT MEDICAL LLC	Saint Paul, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021119558. Last updated year: 2026. Please use registration number 3021119558 when referencing this establishment in official correspondence.