Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011528799

FEI Number

3011528799

Entity Name

OPTEC USA, INC

City/State/Country

SAN PEDRO DE MACORIS, DO

Establishment Address

SOLAR 3, MANZANA 2-B, ZONA FRANCA INDUSTRIAL SAN PEDRO DE MACORIS, SAN PEDRO DE MACORIS XXXX, DO

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OPTEC USA, INC. (Owner Number: 9033352)

Owner / Operator Contact Address

975 PROGRESS CIRCLE, --, Lawrenceville, GA 30043, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

JOINT, HIP, EXTERNAL BRACE ORTHOSIS LUMBO-SACRAL EDGE, EVOTEC, LUMBITEC, OASIS SOFT, PRIMO, SALO, STEALTH, STOCK MINERVA ATTACHMENTS, STOCK STERNAL PAD KIT JOINT, KNEE, EXTERNAL BRACE ORTHOSIS, LUMBAR ORTHOSIS, THORACIC INSOLES, MEDICAL JOINT, SHOULDER, EXTERNAL LIMB COMPONENT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2007-11-19
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2004-02-11
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2012-11-26
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2012-11-26
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2007-11-19
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	1998-03-20
IQQ	Joint, Shoulder, External Limb Component	Physical Medicine	Class 1	890.3420	2012-11-26

Official Correspondent

Daniel Suarez

US Agent Details

NEHEMIAH J. SUAREZ Business: Optec USA, Inc. Email: ar@optecusa.com Phone: (770) 5137380

Related Public Records

Same Entity

OPTEC USA, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1063727	OPTEC USA, INC.	LAWRENCEVILLE, GA, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011528799. Last updated year: 2026. Please use registration number 3011528799 when referencing this establishment in official correspondence.