Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1066368

FEI Number

3003346235

Entity Name

G-5 FLORIDA LLC

City/State/Country

JAX, FL, US

Establishment Address

4801 Dawin Rd, JAX, FL 32207, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

G-5 Florida LLC (Owner Number: 9045425)

Owner / Operator Contact Address

4801 DAWIN RD., --, Jacksonville, FL 32207, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K193256

PMA Number

N/A

All Registered Proprietary Names

NexFlex LineSider Spinal System Anjon Bremer Halo System Anjon Bremer Halo System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2025-01-09
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2021-05-12
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-05-12
JEC	Component, Traction, Invasive	Orthopedic	Class 2	888.3040	2018-03-22
JEC	Component, Traction, Invasive	Orthopedic	Class 2	888.3040	2020-04-06

Official Correspondent

Dean Tulumaris

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

G-5 Florida 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
K963639	Acromed Corp.	ACROMED PEDICLE SCREW	1996-11-14
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05
K252461	Spinal Resources, Inc.	Swedge Pedicle Screw Fixation System Bezier Rod	2026-01-13
K140696	Pioneer Surgical Technology, Inc.	STREAMLINE TL SPINAL FIXATION SYSTEM	2014-04-10
K141398	Medicrea International SA	PASS LP SPINAL SYSTEM	2015-01-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011	Zimmer Inc.	2	SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

Similar Registrations

Registration Number	Establishment Name	Location
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3027473313	ZHEJIANG HOPE PHARMA LTD	Wenzhou Zhejiang, CN
3044994756	SUNMED AP, LTD., WAREHOUSE NO. 2	ZHUHAI Guangdong, CN
2084346	MARINA MEDICAL INSTRUMENTS, INC.	Davie, FL, US
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1066368. Last updated year: 2026. Please use registration number 1066368 when referencing this establishment in official correspondence.