Data / Medical devices / United States / Spineology Inc.

Spineology Inc.: FDA-registered device maker in Saint Paul, MN, United States, 30 510(k) clearances

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

Spineology Inc. is registered with the FDA (registration 2135156) in Saint Paul, MN, United States. It lists 15 device types. The FDA files 30 510(k) clearances under its listings, the newest dated December 15, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2135156
FEI number: 3003179719
Address: 7800 Third Street N. Suite 600, Saint Paul, MN, United States, 55128
Owner or operator: Spineology Inc (9036813)
Roles: Manufacturer
First device listed: March 16, 2001
Registered through: 2026
Brand names listed: Capture Facet Fixation System, ConneX Connectors, Dual Chamber Expandable Interbody Fusion System, Duo Lumbar Interbody Fusion Device, Duo Lumbar Interbody Fusion System, Duo Ti Expandable Interbody Fusion System, Elite Expandable Interbody Fusion System, Fortress Pedicular Fixation System and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Balloon Type	GBA	1	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	KIJ	1	Manufacturer	accessdata.fda.gov
Intervertebral Body Graft Containment Device	OQB	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Lumbar	OVD	2	Manufacturer	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Metal	EZX	2	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Manufacturer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Manufacturer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Manufacturer	accessdata.fda.gov
Retractor	GAD	1	Manufacturer	accessdata.fda.gov
Spinous Process Plate	PEK	2	Manufacturer	accessdata.fda.gov
System, Facet Screw Spinal Device	MRW	U	Manufacturer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Manufacturer	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
December 15, 2025	K251302	OptiMesh Multiplanar Expandable Interbody Fusion System	OQB	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
December 4, 2025	K251943	Spineology Navigation Instruments	OLO	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
November 1, 2023	K230927	OptiMesh Multiplanar Expandable Interbody Fusion System	OQB	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
October 18, 2023	K231781	OptiMesh Multiplanar Expandable Interbody Fusion System	OQB	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
February 19, 2021	K210155	Duo Expandable Interbody Fusion System	MAX	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
September 18, 2020	DEN200010	Spineology Interbody Fusion System	OQB	Unknown	Spineology, Inc.	accessdata.fda.gov
August 23, 2019	K192047	Rampart One Lumbar Interbody Fusion System	OVD	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
May 23, 2019	K191091	Rampart One Lumbar Interbody Fusion System	OVD	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
March 7, 2019	K190055	Duo Lumbar Interbody Fusion Device	MAX	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
October 24, 2018	K182322	Duo Lumbar Interbody Fusion Device	MAX	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
September 21, 2018	K182345	Spineology Navigation Instruments	OLO	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
August 14, 2018	K181792	Duo Lumbar Interbody Fusion Device	MAX	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
May 2, 2018	K180796	Spineology Navigation Instruments	OLO	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
August 21, 2017	K172107	Threshold V2 Pedicular Fixation System, Threshold Pedicular Fixation System, Fortress Pedicular Fixation System, Palisade Pedicular Fixation System	NKB	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
June 2, 2017	K171438	Palisade Pedicular Fixation System	NKB	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
May 8, 2017	K163670	Rampart One Lumbar Interbody Fusion Device	OVD	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
April 14, 2017	K170268	Fortress Pedicular Fixation System	NKB	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
April 14, 2017	K170266	Palisade Pedicular Fixation System	NKB	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
April 14, 2017	K170255	Threshold V2 Pedicular Fixation System	NKB	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
April 14, 2017	K170251	Threshold Pedicular Fixation System	NKB	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
January 30, 2017	K162879	Elite Expandable Interbody Fusion Device	MAX	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
October 18, 2016	K160074	Rampart D Lumbar Interbody Fusion Device	MAX	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
July 15, 2016	K161694	Threshold Pedicular Fixation System	NKB	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
July 14, 2016	K160906	Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device	MAX	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
February 23, 2016	K153323	Palisade Pedicular Fixation System	NKB	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
December 18, 2014	K143403	Threshold Pedicular Fixation System	NKB	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
September 10, 2014	K142213	VIA SPINOUS PROCESS FIXATION SYSTEM	PEK	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
April 23, 2014	K140010	FORTRESS PEDICLE SCREW SYSTEM	NKB	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
November 9, 2009	K092464	SPINEOLOGY FACET SCREW	MRW	Substantially Equivalent	Spineology, Inc.	accessdata.fda.gov
November 26, 2003	K014200	OPTIMESH	EZX	Unknown	Spineology, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 16, 2024	95341	Class II	Ongoing	The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced through the Access Portal. A Push Rod is then used to facilitate the manual deployment of the graft m	Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.	accessdata.fda.gov
January 28, 2005	31198	Not yet classified	Terminated	Fill Tube,diverted, Catalog #, is used for the delivery of granular autograft or allograft into Spineology''s OptiMesh implant. Fill tube is identified with Spineology, catalog number and lot number printed directly onto	Three malfunctions, due to jamming of bone material in the fill tube occurred, which allowed the fill tube to advance more deeply than intended into the surgical site. Fill tubes are used in delivery of bone graft materials.	accessdata.fda.gov

Compare with other makers

Updated December 15, 2025. 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.