OPTEC USA, INC.

FDA Device Registration & Listing · LAWRENCEVILLE, GA, US · Registration 1063727

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
1063727
FEI Number
3001779564
Entity Name
OPTEC USA, INC.
City/State/Country
LAWRENCEVILLE, GA, US
Establishment Address
975 PROGRESS CIRCLE, LAWRENCEVILLE, GA 30043, US
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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

JOINT, HIP, EXTERNAL BRACE JOINT, KNEE, EXTERNAL BRACE OPTEC LIMB ORTHOSIS, THORACIC ORTHOSIS LUMBO-SACRAL EDGE, EVOTEC, LUMBITEC, OASIS SOFT, PRIMO, SALO, STEALTH, STOCK MINERVA ATTACHMENTS, STOCK STERNAL PAD KIT ORTHOSIS, CERVICAL-THORACIC, RIGID ORTHOSIS LUMBO-SACRAL EDGE, EVOTEC, LUMBITEC, OASIS SOFT, PRIMO, SALO, STEALTH, STOCK MINERVA ATTACHMENTS, STOCK STERNAL PAD KIT 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
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2012-11-26
MRI Orthosis, Truncal/Orthosis, Limb Physical Medicine Class 1 890.3490 2012-11-26
IPT Orthosis, Thoracic Physical Medicine Class 1 890.3490 2007-11-19
IPY Orthosis, Lumbo-Sacral Physical Medicine Class 1 890.3490 2004-02-11
IQF Orthosis, Cervical-Thoracic, Rigid Physical Medicine Class 1 890.3490 2007-11-19
IPY Orthosis, Lumbo-Sacral Physical Medicine Class 1 890.3490 2004-02-11
IQQ Joint, Shoulder, External Limb Component Physical Medicine Class 1 890.3420 2012-11-26

Official Correspondent

Daniel Suarez

US Agent Details

No US Agent registered (Local establishment).

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
3011528799 OPTEC USA, INC SAN PEDRO DE MACORIS, DO

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1063727. Last updated year: 2026. Please use registration number 1063727 when referencing this establishment in official correspondence.
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