TETROUS, INC.

FDA Device Registration & Listing · Oak Brook, IL, US · Registration 3029780995

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3029780995
FEI Number
3029780995
Entity Name
TETROUS, INC.
City/State/Country
Oak Brook, IL, US
Establishment Address
2021 Midwest Rd Ste 101, Oak Brook, IL 60523, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Tetrous, Inc. (Owner Number: 10090043)
Owner / Operator Contact Address
2021 Midwest Road, Suite 101, Oak Brook, IL 60523, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

EnFix Instrument Tray EnFix Guide Wire Tetrous Guide Wire EnFix Introducer Probe EnFix Awl

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2025-05-15
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2026-02-16
HXB Probe Orthopedic Class 1 888.4540 2024-02-06
HWJ Awl Orthopedic Class 1 888.4540 2024-02-06

Official Correspondent

Andy Carter

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tetrous, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029780995. Last updated year: 2026. Please use registration number 3029780995 when referencing this establishment in official correspondence.
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