Data / Medical devices / United States / SpineSmith Holdings, LLC

SpineSmith Holdings, LLC: FDA-registered device maker in Austin, TX, United States, 21 510(k) clearances

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

SpineSmith Holdings, LLC is registered with the FDA (registration 3006404071) in Austin, TX, United States. It lists 16 device types. The FDA files 21 510(k) clearances under its listings, the newest dated January 10, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006404071
Address: 4719 South Congress Ave., Austin, TX, United States, 78745
Owner or operator: SpineSmith Holdings,LLC (9104820)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed: October 3, 2008
Registered through: 2026
Brand names listed: #2130ac RF Dispersive Electrode, AC-SN-DUS, ART 2-Step PRP, ART BMC, ART BMC Plus, ART PRP, ART PRP Plus, Appliance, fixation, spinal intervertebral body and more

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Holder, Syringe	IQG	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	JQC	1	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Filler, Bone Void, Calcium Compound	MQV	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Cervical	OVE	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Lumbar	OVD	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Platelet And Plasma Separator For Bone Graft Handling	ORG	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Spinal Vertebral Body Replacement Device	MQP	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
System, Facet Screw Spinal Device	MRW	U	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	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
January 10, 2020	K193465	CorticaLINK Spinal Fusion Platform	NKB	Substantially Equivalent	Spine Smith Holdings, LLC	accessdata.fda.gov
January 17, 2018	K173582	ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes	GEI	Substantially Equivalent	Thermigen, L.L.C	accessdata.fda.gov
December 11, 2017	K173484	CorticaLINK Spinal Fusion Platform	NKB	Substantially Equivalent	Linkspine, Inc.	accessdata.fda.gov
May 8, 2017	K171094	Thermi Reusable Non-invasive RF Electrode	GEI	Substantially Equivalent	Thermgen, L.L.C	accessdata.fda.gov
March 29, 2017	K162693	VertebraLINK Fusion Platform	MAX	Substantially Equivalent	Facetlink Dba Linkspine	accessdata.fda.gov
March 13, 2017	K170116	Thermi Injectable RF Electrodes	GEI	Substantially Equivalent	Thermi	accessdata.fda.gov
August 12, 2016	K161661	Thermi RF Accessories	GEI	Substantially Equivalent	Thermi	accessdata.fda.gov
July 7, 2016	K160722	CorticaLINK Spinal Fusion Platform	NKB	Substantially Equivalent	Facetlink Dba Linkspine	accessdata.fda.gov
April 28, 2015	K150223	Facet-Link Stabilization Platform	MRW	Substantially Equivalent	Facet-Link, Inc.	accessdata.fda.gov
May 21, 2014	K132470	SOLUM IV BONE VOID FILLER	MQV	Substantially Equivalent	Spinesmith Partners, Llp	accessdata.fda.gov
November 15, 2013	K130689	SYMPHONY RF GENERATOR	GEI	Substantially Equivalent	Thermigen, Inc.	accessdata.fda.gov
February 28, 2013	K123497	FACET SCREW SYSTEM	MRW	Substantially Equivalent	Facet-Link, Inc.	accessdata.fda.gov
December 5, 2012	K122630	IN:C2 SPINAL FIXATION SYSTEM	OVE	Substantially Equivalent	Spine Smith Partners L.P.	accessdata.fda.gov
October 11, 2012	K122168	VISUALIF CHALLENGING ACCESS PLATE	OVD	Substantially Equivalent	Spine Smith Partners L.P.	accessdata.fda.gov
November 3, 2010	K102372	OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB	GEI	Substantially Equivalent	Jiangmen City Xinhui Baisheng Medical Equipment CO	accessdata.fda.gov
September 30, 2010	K102090	SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM	OVD	Substantially Equivalent	Spine Smith Partners L.P.	accessdata.fda.gov
July 1, 2010	K101085	SPINESMITH CYNCH SPINAL SYSTEM	MAX	Substantially Equivalent	Spine Smith Partners L.P.	accessdata.fda.gov
April 1, 2009	K090376	SPINESMITH CYNCH SPINAL SYSTEM	MAX	Substantially Equivalent	Spine Smith Partners L.P.	accessdata.fda.gov
July 14, 2008	K081132	SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM	KWQ	Substantially Equivalent	Spine Smith Partners L.P.	accessdata.fda.gov
July 2, 2008	K080971	SPINESMITH CIMPLICITY SPINAL SYSTEM	MQP	Substantially Equivalent	Spine Smith Partners L.P.	accessdata.fda.gov
February 7, 2008	K073320	CIMPLICITY SPINAL SYSTEM	ODP	Substantially Equivalent	Spine Smith Partners L.P.	accessdata.fda.gov

Compare with other makers

Updated January 10, 2020. 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.