Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010396722

FEI Number

3010396722

Entity Name

INFINITUS MEDICAL TECHNOLOGIES LLC

City/State/Country

Holly Springs, NC, US

Establishment Address

242 South Main St, Suite 214, Holly Springs, NC 27540, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Infinitus Medical Technologies LLC (Owner Number: 10044733)

Owner / Operator Contact Address

1308 Honey Locust Ct, Raleigh, NC 27606, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

COVID19 Reponse PPE Hood IMT Surgical Replacement pad set for various surgical table manufactures Mizuho Hana Table Pad and Strap PN FPLS-1210SP The Kyber SSC Retractor assembly AXR-2000 Pressure Management Foam Wedge LUNA Supine Pad SP-3500 Azul ITPW Pneuma Hadron FPLS (inflatable assist positioning system) The Hadron FPLS" Foam Pad Lift System Visiwrap Robotic face protection system CHST-3000 Chest Pad and Chest Strap Accessory Kit Pneuma Genesis Bi-Wing AAP Inflatable Assist Positioning System FPLS-3000-Wing ION ESPS Foam insert The Genesis Bi-Wing AAP arm adduction pad The iON ESPS ergonomic surgical postioning system

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-04-16
LWG	Surgical Table Cushion	General, Plastic Surgery	Class 1	878.4950	2021-12-23
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2017-01-08
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2013-07-19

Official Correspondent

David Gomez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Infinitus Medical Technologies 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
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010396722. Last updated year: 2026. Please use registration number 3010396722 when referencing this establishment in official correspondence.