Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008584163

FEI Number

3008584163

Entity Name

PROTEOR USA

City/State/Country

Tempe, AZ, US

Establishment Address

1236 W SOUTHERN AVE STE 101, Tempe, AZ 85282, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

PROTEOR USA (Owner Number: 10032353)

Owner / Operator Contact Address

1236 West Southern Avenue, Suite 101, Tempe, AZ 85282, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PRONG CONNECTOR AND DISH FOAM COVERING 4-AXIS KNEE Easy Ride BASE TUBE Trans-Femoral Rotator HyTrek THREAD CONNECTION ADAPTOR DISTAL LOCKING Proteor Quattro Microprocessor Knee SINGLE AXIS KNEE W/BRAKE FEMALE PYRAMID CONNECTOR Hydeal Knee CONNECTION ADAPTOR Matik Knee LOCKING KNEE COMPACT 4-AXIS KNEE SYNSYS Leg KEASY Stepline ADJUS TEMPORARY SOCKET Silitouch Aflex ANKLE Valve

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISY	Joint, Knee, External Limb Component	Physical Medicine	Class 1	890.3420	2019-01-31
ISW	Assembly, Knee/Shank/Ankle/Foot, External	Physical Medicine	Class 2	890.3500	2023-02-20
ISS	Prosthesis, Thigh Socket, External Component	Physical Medicine	Class 1	890.3420	2021-01-21
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2019-01-31
ISP	Valve, Prosthesis	Physical Medicine	Class 1	890.3420	2021-06-17

Official Correspondent

Valery Barbour

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PROTEOR USA

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004737223	PROTEOR USA, Gunnison	Gunnison, UT, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008584163. Last updated year: 2026. Please use registration number 3008584163 when referencing this establishment in official correspondence.