SPINAL ELEMENTS, INC.

Registration Details

Registration Name: SPINAL ELEMENTS, INC.
Registration Number: 3004893332
FEI Number: 3004893332
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 3115 Melrose Dr Suite 200
City: CARLSBAD
State: CA
ZIP: 92010
Country: US

Regulatory Submissions

510(k) Number: K102594

Owner / Operator

Firm Name: Spinal Elements
Operator Number: 9048980
Address: 3115 Melrose Dr Suite 200
City: Carlsbad
State: CA
Postal Code: 92010
Country: US
Correspondent: Sartaj Kaur-Hurrle

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Catheter, Conduction, Anesthetic	BSO	Class 2	Anesthesiology	No	2015-03-19
Stimulator, Nerve	ETN	Class 2	Ear, Nose, Throat	No	2015-03-19
System, Facet Screw Spinal Device	MRW	Class U	Unknown	No	2010-12-20
Appliance, Fixation, Spinal Intervertebral Body	KWQ	Class 2	Orthopedic	No	2017-12-22
Rongeur, Manual	HAE	Class 2	Neurology	No	2015-03-19
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	Class 2	Orthopedic	No	2015-01-02
Appliance, Fixation, Spinal Interlaminal	KWP	Class 2	Orthopedic	No	2025-12-02
Orthopedic Stereotaxic Instrument	OLO	Class 2	Neurology	No	2025-12-02
Thoracolumbosacral Pedicle Screw System	NKB	Class 2	Orthopedic	No	2025-12-02
Orthopedic Manual Surgical Instrument	LXH	Class 1	Orthopedic	No	2012-10-26
Light, Surgical, Fiberoptic	FST	Class 2	General, Plastic Surgery	No	2017-12-22
Neurological Stereotaxic Instrument	HAW	Class 2	Neurology	No	2006-10-05
Bone Fixation Cerclage, Sublaminar	OWI	Class 2	Orthopedic	No	2019-04-04
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	Class 2	Orthopedic	No	2023-06-01
Intervertebral Fusion Device With Integrated Fixation, Cervical	OVE	Class 2	Orthopedic	No	2017-12-22
Orthosis, Spondylolisthesis Spinal Fixation	MNH	Class 2	Orthopedic	No	2018-11-28
Orthosis, Spinal Pedicle Fixation	MNI	Class 2	Orthopedic	No	2018-11-28
Cerclage, Fixation	JDQ	Class 2	Orthopedic	No	2018-11-28
Pin, Fixation, Smooth	HTY	Class 2	Orthopedic	No	2011-12-21
Pin, Fixation, Threaded	JDW	Class 2	Orthopedic	No	2011-12-21
Spinal Vertebral Body Replacement Device	MQP	Class 2	Orthopedic	No	2007-12-05
Intervertebral Fusion Device With Integrated Fixation, Lumbar	OVD	Class 2	Orthopedic	No	2017-12-22
Arthroscope	HRX	Class 2	Orthopedic	No	2010-12-20
Bit, Drill	HTW	Class 1	Orthopedic	No	2012-07-24
Tray, Surgical, Instrument	FSM	Class 1	General, Plastic Surgery	No	2012-07-24
Posterior Cervical Screw System	NKG	Class 2	Orthopedic	No	2017-12-22
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	OSH	Class 2	Orthopedic	No	2016-12-30
Spinous Process Plate	PEK	Class 2	Orthopedic	No	2017-12-22
Burr, Orthopedic	HTT	Class 1	Orthopedic	No	2012-09-09

Proprietary Names

iO-Flex iO-Flex Neuro Check iO-Flex MicroBlade Shaver Primus Spinal Fixation System Guide Wire Depth Sounder Guide Disc Shaper Broach Hex Driver Screwdriver Temporary Fixation Pin Tap Tulip Adjuster Rod Bender Ejector Distraction Pin Driver Depth Tool Graft Block Counter Torque Set Screw Starter Post Remover Pedicle Marker Dual Stylet Needle Pin Inserter Inserter Tulip Positioner Pedicle Feeler Awl Nerver Root Retractor Access Portal Chisel Box Chisel Reducer Compactor Cannula Hex Adapter Crow Foot Distraction Pin Trial Plate Shaver Elevator Spacer Sleeve Cobb Removal Tool Tab Cutter Compressor Fulcrum Packing Block Curette Dilator Lodestar Tab Extender Plate Bender Tower Clip Pusher Crown Trephine Probe Tab Breaker Distractor Retainer Suction Tube Screw Adjuster Plate Holder Osteotome Hammer Disc Shaver Rasp Stabilizer Handle Rocker Hex Retainer Adaptor Retractor Rod Template Wrench Persuader Rongeur Disc Cutter Drill Rod Gripper Funnel Compressor Temporary Fixation Screw Caliper Sizer Nerve Sheild Tamp Rod Holder Marquise MIS Channel Karma® Fixation System Ventana A Anterior Lumbar Interbody System Lucent® XP

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device