Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006404071

FEI Number

3006404071

Entity Name

SpineSmith Holdings, LLC

City/State/Country

AUSTIN, TX, US

Establishment Address

4719 South Congress Ave., AUSTIN, TX 78745, US

Establishment Type(s)

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

Owner / Operator

SpineSmith Holdings,LLC (Owner Number: 9104820)

Owner / Operator Contact Address

4719 South Congress Ave., --, Austin, TX 78745, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161661

PMA Number

N/A

All Registered 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 Intervertebral fusion device with bone graft, lumbar 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2008-10-03
IQG	Adaptor, Holder, Syringe	Physical Medicine	Class 1	890.5050	2025-04-11
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2008-10-03
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2008-10-03
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2010-11-29
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2023-09-17
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2016-09-16
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2016-03-31
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2009-12-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-08-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-08-31
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2010-11-29
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2013-06-13
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2014-02-28
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2023-09-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-08-31

Official Correspondent

Chriselda Martinez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SpineSmith Holdings,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
K041888	Signus Medizintechnik GmbH	CURVED PEEK TETRIS SPINAL IMPLANT	2004-08-10
K211892	Arftx Medical, LLC	ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)	2022-10-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2012	Osteomed, Lp 3885 Arapaho Rd Addison TX 75001	U	OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

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3021588295	XYRESIC LLC	Jackson, MI, US
3036496433	SPECTRUM SPINE INC	Jasper, GA, US
3027726367	HAPPE SPINE	Grand Rapids, MI, US
3027201862	XCIX DESIGN, LLC	Richmond, UT, US
3017936978	CARLSMED, INC.	Carlsbad, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006404071. Last updated year: 2026. Please use registration number 3006404071 when referencing this establishment in official correspondence.