Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011513267

FEI Number

3011513267

Entity Name

FLOSPINE LLC

City/State/Country

Boca Raton, FL, US

Establishment Address

3998 FAU Blvd, Suite 300, Boca Raton, FL 33431, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FloSpine LLC (Owner Number: 10048786)

Owner / Operator Contact Address

3998 FAU Blvd, Suite 300, Boca Raton, FL 33431, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Canaveral Pedicle Screw System Ti-Largo Canaveral Pedicle Screw System Panama Anterior Cervical Plate System Ti-Largo Canaveral Pedicle Screw System Panama Anterior Cervical Plate System Canaveral Pedicle Screw System KeyLift Expandable Interlaminar Stabilization System Canaveral Pedicle Screw System Ti-Largo Panama Anterior Cervical Plate System KeyLift Expandable Interlaminar Stabilization System KeyLift Expandable Interlaminar Stabilization System Canaveral Pedicle Screw System KeyLift Expandable Interlaminar Stabilization System Canaveral Pedicle Screw System Panama Anterior Cervical Plate System Canaveral Pedicle Screw System Panama Anterior Cervical Plate System KeyLift Expandable Interlaminar Stabilization System Canaveral Pedicle Screw System Canaveral Pedicle Screw System Panama Anterior Cervical Plate System Ti-Largo Canaveral Pedicle Screw System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-12-20
LYQ	Accessories, Fixation, Spinal Intervertebral Body	Orthopedic	Class 1	888.4540	2025-02-03
HXW	Bender	Orthopedic	Class 1	888.4540	2016-12-20
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-02-03
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2016-12-20
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2021-08-19
KTZ	Caliper	Orthopedic	Class 1	888.4150	2016-12-20
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2025-02-03
HXC	Wrench	Orthopedic	Class 1	888.4540	2016-12-20
HXG	Tamp	Orthopedic	Class 1	888.4540	2025-02-03
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2021-09-23
KDG	Chisel (Osteotome)	General, Plastic Surgery	Class 1	878.4820	2025-02-03
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2025-02-03
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2016-12-20
HTX	Rongeur	Orthopedic	Class 1	888.4540	2025-02-04
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2016-12-20
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2016-12-20
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2025-02-03
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2016-12-20
HWJ	Awl	Orthopedic	Class 1	888.4540	2016-12-20
HTP	File	Orthopedic	Class 1	888.4540	2025-02-03
HXB	Probe	Orthopedic	Class 1	888.4540	2016-12-20

Official Correspondent

Waldi Harris

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FloSpine 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
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09
K122085	Omni Surgical, LP Dba Spine360	STINGRAY CERVICAL CAGE	2012-10-17
K120275	Synthes (Usa), LLC	SYNTHES ACIS/VERTEBRAL SPACER CR	2012-05-25
K032752	R&B Surgical Solutions, LLC	R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM	2003-12-03
K062643	Life Spine	KINETIC ANTERIOR CERVICAL PLATE	2006-11-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013	Medtronic Sofamor Danek USA Inc	2	PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05	Zimmer Spine, Inc.	2	ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011513267. Last updated year: 2026. Please use registration number 3011513267 when referencing this establishment in official correspondence.