Data / Medical devices / United States / Flospine LLC

Flospine LLC: FDA-registered device maker in Boca Raton, FL, United States, 4 510(k) clearances

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

Flospine LLC is registered with the FDA (registration 3011513267) in Boca Raton, FL, United States. It lists 30 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 19, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011513267
Address: 3998 FAU Blvd Suite 300, Boca Raton, FL, United States, 33431
Owner or operator: FloSpine LLC (10048786)
Roles: Manufacturer
First device listed: February 27, 2015
Registered through: 2026
Brand names listed: Canaveral Deformity Screw System, Canaveral Minimally Invasive Screw System, Canaveral Pedicle Screw System, KeyLift Expandable Interlaminar Stabilization System, Panama Anterior Cervical Plate System, Panama Anterior Cervical Plate System, Ti-Largo

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Fixation, Spinal Intervertebral Body	LYQ	1	Manufacturer	accessdata.fda.gov
Appliance, Fixation, Spinal Interlaminal	KWP	2	Manufacturer	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Manufacturer	accessdata.fda.gov
Awl	HWJ	1	Manufacturer	accessdata.fda.gov
Bender	HXW	1	Manufacturer	accessdata.fda.gov
Bit, Drill	HTW	1	Manufacturer	accessdata.fda.gov
Caliper	KTZ	1	Manufacturer	accessdata.fda.gov
Chisel (Osteotome)	KDG	1	Manufacturer	accessdata.fda.gov
File	HTP	1	Manufacturer	accessdata.fda.gov
Instrument, Bending Or Contouring	HXP	1	Manufacturer	accessdata.fda.gov
Instrument, Compression	HWN	1	Manufacturer	accessdata.fda.gov
Instrument, Cutting, Orthopedic	HTZ	1	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Manufacturer	accessdata.fda.gov
Mallet	HXL	1	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Manufacturer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Manufacturer	accessdata.fda.gov
Osteotome	HWM	1	Manufacturer	accessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	OSH	2	Manufacturer	accessdata.fda.gov
Pliers, Surgical	HTC	1	Manufacturer	accessdata.fda.gov
Probe	HXB	1	Manufacturer	accessdata.fda.gov
Pusher, Socket	HXO	1	Manufacturer	accessdata.fda.gov
Rasp	HTR	1	Manufacturer	accessdata.fda.gov
Rongeur	HTX	1	Manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Manufacturer	accessdata.fda.gov
Spinous Process Plate	PEK	2	Manufacturer	accessdata.fda.gov
Tamp	HXG	1	Manufacturer	accessdata.fda.gov
Tap, Bone	HWX	1	Manufacturer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Manufacturer	accessdata.fda.gov
Wrench	HXC	1	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
October 19, 2023	K232484	KeyLift Expandable Interlaminar Stabilization System	PEK	Substantially Equivalent	Amplio Spine, LLC	accessdata.fda.gov
February 24, 2023	K223231	Ti-Largo Cervical Interbody System	ODP	Substantially Equivalent	Flospine	accessdata.fda.gov
April 7, 2021	K210182	PANAMA Anterior Cervical Plate (ACP) System	KWQ	Substantially Equivalent	Flospine	accessdata.fda.gov
October 27, 2014	K141850	FLOSPINE PEDICLE SCREW SYSTEM	NKB	Substantially Equivalent	Flospine	accessdata.fda.gov

Compare with other makers

Updated October 19, 2023. 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.