SpineSmith Holdings, LLC

Registration Details

Registration Name: SpineSmith Holdings, LLC
Registration Number: 3006404071
FEI Number: 3006404071
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 4719 South Congress Ave.
City: AUSTIN
State: TX
ZIP: 78745
Country: US

Regulatory Submissions

510(k) Number: K073320

Owner / Operator

Firm Name: SpineSmith Holdings,LLC
Operator Number: 9104820
Address: 4719 South Congress Ave., --
City: Austin
State: TX
Postal Code: 78745
Country: US
Correspondent: Chriselda Martinez

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	Class 2	Orthopedic	No	2008-10-03
Adaptor, Holder, Syringe	IQG	Class 1	Physical Medicine	No	2025-04-11
Spinal Vertebral Body Replacement Device	MQP	Class 2	Orthopedic	No	2008-10-03
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	Class 2	Orthopedic	No	2010-11-29
System, Facet Screw Spinal Device	MRW	Class U	Unknown	No	2023-09-17
Filler, Bone Void, Calcium Compound	MQV	Class 2	Orthopedic	No	2016-09-16
Platelet And Plasma Separator For Bone Graft Handling	ORG	Class 2	Hematology	No	2016-03-31
Electrosurgical, Cutting & Coagulation & Accessories	GEI	Class 2	General, Plastic Surgery	No	2023-08-31
Intervertebral Fusion Device With Integrated Fixation, Lumbar	OVD	Class 2	Orthopedic	No	2010-11-29
Intervertebral Fusion Device With Integrated Fixation, Cervical	OVE	Class 2	Orthopedic	No	2013-06-13
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	JQC	Class 1	Clinical Chemistry	No	2014-02-28
Orthosis, Spinal Pedicle Fixation	MNI	Class 2	Orthopedic	No	2023-09-17
Thoracolumbosacral Pedicle Screw System	NKB	Class 2	Orthopedic	No	2023-09-17
Orthosis, Spondylolisthesis Spinal Fixation	MNH	Class 2	Orthopedic	No	2023-09-17
Appliance, Fixation, Spinal Intervertebral Body	KWQ	Class 2	Orthopedic	No	2008-10-03
Needle, Aspiration And Injection, Disposable	GAA	Class 1	General, Plastic Surgery	No	2026-01-05

Proprietary Names

Intervertebral fusion device with bone draft, cervical Celling Application Kit Celling Cardio Application Kit Intervertebral fusion device with bone graft, cervical Spinal vertebral body replacement device Intervertebral fusion device with bone graft, lumbar Facet Screw System Solum ART PRP ART PRP Plus Thermi Temp Controlled RF System (Generator, percutaneous RFE & RFDE electrodes/handpieces, Foot Pedal, Power cord) Thermi RF+ Thermi Reusable Non-Invasive RF Elecrode RFE-15-D Intervertebral fusion device with integrated fixation, lumbar Intervertebral fusion device with integrated fixation, cervical Celling Centrifuge Facet Screw Spinal Device System AC-SN-DUS Thermi RF Accessories RFDE-5 RFDE-10 RFDE-15 Orthosis, spinal pedicle fixation Thoracolumbosacral pedicle screw system Orthosis, spondylolisthesis spinal fixation Cortical LINK Spinal Fusion Platform ThermiEye RFDE-VA ThermiSmooth Thermi RF RFE-10-D ThermiVA V-10-10-18-B V-5-5-20-B V-20-10-16-B Thermi Injectable RF Electrode V-15-10-18-B Electrosurgical Pad #2130ac RF Dispersive Electrode ART BMC Plus ART BMC ART 2-Step PRP Appliance, fixation, spinal intervertebral body Intervertebral Body Fusion Device Solum Convenience Kit

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device