Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006982954

FEI Number

3006982954

Entity Name

VGI medical, LLC

City/State/Country

Largo, FL, US

Establishment Address

11651 87th St, Largo, FL 33773, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

VGI Medical, LLC (Owner Number: 10026541)

Owner / Operator Contact Address

11651 87th St, Largo, FL 33773, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Facet Distractor VerteLP Implant Tamp Implant Loading Block Tapping Cap Drill Guide Directional Cannula Positive Stop Drill Bit Implant Holder Guide Wire

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2008-07-29
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2016-01-15
HXG	Tamp	Orthopedic	Class 1	888.4540	2008-07-29
IQG	Adaptor, Holder, Syringe	Physical Medicine	Class 1	890.5050	2008-07-29
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2008-07-29
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2008-07-29
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2008-07-29
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2008-07-29
IQG	Adaptor, Holder, Syringe	Physical Medicine	Class 1	890.5050	2008-07-29
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2008-07-29

Official Correspondent

Tov Vestgaarden

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

VGI Medical, 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
K192492	Astura Medical, LLC	EL CAPITAN Anterior Lumber Interbody System	2020-04-21
K212498	Nexus Spine, LLC	Stable-L Standalone Lumbar Interbody System	2022-03-18
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.

Similar Registrations

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1020279	SMITH & NEPHEW, INC.	MEMPHIS, TN, US
3004215117	MILLENNIUM SURGICAL CORP	Schaumburg, IL, US
3012755988	Ortho Solutions Sdn Bhd	Prai, Penang Pulau Pinang, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006982954. Last updated year: 2026. Please use registration number 3006982954 when referencing this establishment in official correspondence.