Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009383407

FEI Number

3009383407

Entity Name

MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USA

City/State/Country

Newnan, GA, US

Establishment Address

98 Bledsoe Road, Newnan, GA 30265, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Matrix Surgical Holdings, LLC. dba Matrix Surgical USA (Owner Number: 10038239)

Owner / Operator Contact Address

98 Bledsoe Road, Newnan, GA 30265, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133046

PMA Number

N/A

All Registered Proprietary Names

Seiff Ptosis Sling OmniPore Customized Surgical Implant HTR-OMNIPORE Patient Matched Implant

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HJZ	Crutch, Ptosis	Ophthalmic	Class 1	886.5600	2025-05-01
KKY	Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction	General, Plastic Surgery	Class 2	878.3500	2014-06-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Matrix Surgical Holdings, LLC. dba Matrix Surgical USA

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
K080507	Ceremed , Inc.	AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT	2008-04-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009383407. Last updated year: 2026. Please use registration number 3009383407 when referencing this establishment in official correspondence.