Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005694091

FEI Number

3005694091

Entity Name

RE:BUILD TEKNA, LLC

City/State/Country

KALAMAZOO, MI, US

Establishment Address

3665 Midlink Drive, KALAMAZOO, MI 49048, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Re:Build Tekna, LLC (Owner Number: 9083159)

Owner / Operator Contact Address

3665 Midlink Drive, --, Kalamazoo, MI 49048, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Generator Cart StrykerVision Mount Connected OR Cart Multi-Specialty Cart Standard Cart Micro Cart Auxiliary Cart Neurotech Cart, 120V Video Cart TEKNA MEDICAL EQUIPMENT CARTS MTS Filter Kit MTS225 GETINGE Cabinet MTS225 Cabinet, Steris 600 MTS225 Transfer Cart, Steris 600 MTS225 GETINGE Transfer Cart

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2017-01-08
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2006-02-17
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2026-01-13

Official Correspondent

MATT HEINTZ

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Re:Build Tekna, 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
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005694091. Last updated year: 2026. Please use registration number 3005694091 when referencing this establishment in official correspondence.