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G-5 Florida LLC: FDA-registered device maker in Jax, FL, United States, 3 510(k) clearances

Name: G-5 Florida LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

G-5 Florida LLC is registered with the FDA (registration 1066368) in Jax, FL, United States. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 23, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1066368
FEI number: 3003346235
Address: 4801 Dawin Rd, Jax, FL, United States, 32207
Owner or operator: G-5 Florida LLC (9045425)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: March 22, 2018
Registered through: 2026
Brand names listed: Anjon Bremer Halo System, LineSider Spinal System, NexFlex, Next Science Xperience, OsteoFlo 10cc Syringe, OsteoFlo 10cc Tube, OsteoFlo 1cc Syringe, OsteoFlo 2.5cc Syringe and more

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Spinal Interlaminal	KWP	2	Contract manufacturer	accessdata.fda.gov
Component, Traction, Invasive	JEC	2	Manufacturer	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Repackager or relabeler	accessdata.fda.gov
Filler, Bone Void, Calcium Compound	MQV	2	Contract manufacturer	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Contract manufacturer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 23, 2021	K203835	MIS Solution	FRO	Substantially Equivalent	Next Science, LLC	accessdata.fda.gov
March 2, 2020	K193256	Anjon Bremer Halo System	JEC	Substantially Equivalent	Anjon Holdings, LLC	accessdata.fda.gov
March 19, 2018	K171863	Anjon Bremer Halo System	JEC	Substantially Equivalent	Anjon Holdings, LLC	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 18, 2020	85958	Class II	Terminated	Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for	High rate of galling of one threaded component.	accessdata.fda.gov

Compare with other makers

Updated April 23, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.