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SPINEOLOGY INC.

Last updated September 17, 2026

What SPINEOLOGY INC. makes

Spineology Inc. manufactures spinal fusion devices, including metallic and polymeric interbody fusion cages, non-bioabsorbable spinal bone screws, and internal spinal fixation systems with rods. Their portfolio also includes reusable surgical implant templates, retractors, and bone graft pouches for vertebral body applications. Devices like expandable interbody systems and pedicle fixation sets are designed for spinal stabilization procedures.

The company’s products are regulated under FDA’s Class I, Class II, and Unclassified (U) categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Spineology Inc. is headquartered in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: 7800 THIRD STREET N., Saint Paul, MN, 55128
Website: spineology.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 651-256-8500
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3003179719
DUNS Number: 033014361

Catalogue (1995)

Page 40 of 40

Device	Model / Reference	Registries	Class	Status
Duo Expandable Interbody Fusion System	K210155	FDA 510(k)	Class II	Active
Rampart L Lumbar Interbody Fusion Device	K171724	FDA 510(k)	Class II	Active
Threshold™ Pedicular Fixation System	K161694	FDA 510(k)	Class II	Active
Spineology Facet Screw	K092464	FDA 510(k)	U	Active
Spineology Peek Bullet Lumbar Interbody Fusion Device	K113030	FDA 510(k)	Class II	Active
Palisade Pedicular Fixation System	K153323	FDA 510(k)	Class II	Active
Spineology Peek Lumbar Interbody Fusion Device	K110933	FDA 510(k)	Class II	Active
Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System	K172107	FDA 510(k)	Class II	Active
Fortress Pedicle Screw System	K140010	FDA 510(k)	Class II	Active
Rampart O	K131216	FDA 510(k)	Class II	Active
Palisade™ Pedicular Fixation System	K171438	FDA 510(k)	Class II	Active
Palisade™ Pedicular Fixation System	K170266	FDA 510(k)	Class II	Active
Duo Lumbar Interbody Fusion Device	K171660	FDA 510(k)	Class II	Active
Fortress Pedicular Fixation System	K152148	FDA 510(k)	Class II	Active
Rampart One Lumbar Interbody Fusion System	K191091	FDA 510(k)	Class II	Active
Spineology Navigation Instruments	K182345	FDA 510(k)	Class II	Active
Duo Lumbar Interbody Fusion Device	K182322	FDA 510(k)	Class II	Active
Optimesh	K014200	FDA 510(k)	Class II	Active
Rampart One Lumbar Interbody Fusion Device	K180002	FDA 510(k)	Class II	Active
Threshold Pedicular Fixation System, Palisade Pedicular Fixation System	K160980	FDA 510(k)	Class II	Active
Rampart-T Interbody Fusion System	K151020	FDA 510(k)	Class II	Active
Rampart O And Rampart P	K130396	FDA 510(k)	Class II	Active
Spineology Navigation Instruments	K213876	FDA 510(k)	Class II	Active
Duo™ Lumbar Interbody Fusion Device	K181792	FDA 510(k)	Class II	Active
Threshold™ Pedicular Fixation System	K170251	FDA 510(k)	Class II	Active
Spineology Peek Lumbar Interbody Fusion Drive	K120293	FDA 510(k)	Class II	Active
Elite Expandable Interbody Fusion Device	K162879	FDA 510(k)	Class II	Active
OptiMesh Multiplanar Expandable Interbody Fusion System	K230927	FDA 510(k)	Class II	Active
Rampart D Lumbar Interbody Fusion Device	K160074	FDA 510(k)	Class II	Active
Spineology Navigation Instruments	K180796	FDA 510(k)	Class II	Active
Fortress™ Pedicular Fixation System	K170268	FDA 510(k)	Class II	Active
Threshold Pedicular Fixation System	K143403	FDA 510(k)	Class II	Active
K-Centrum Anterior Spinal Fixation System	K002371	FDA 510(k)	Class II	Active
Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device	K160906	FDA 510(k)	Class II	Active
Spineolgy Peek Bullet Lumber Interbody Fusion Device	K111880	FDA 510(k)	Class II	Active
Spineology Navigation Instruments	K251943	FDA 510(k)	Class II	Active
Spineology Peek Lumbar Interbody Fusion Device	K121129	FDA 510(k)	Class II	Active
Rampart(TM) T Lumbar Interbody Fusion Device	K163409	FDA 510(k)	Class II	Active
Threshold™ V2 Pedicular Fixation System	K170255	FDA 510(k)	Class II	Active
Rampart One Lumbar Interbody Fusion Device	K163670	FDA 510(k)	Class II	Active
Spineology Spinous Process Plate	K123232	FDA 510(k)	Class II	Active
Via Spinous Process Fixation System	K142213	FDA 510(k)FDA UDI	Class II	Active
Spineology Peek Lumbar Interbody Fusion Device	K123652	FDA 510(k)	Class II	Active
Rampart™ One Lumbar Interbody Fusion System	K192047	FDA 510(k)	Class II	Active
Rampart A Lumbar Interbody Fusion Device	K153082	FDA 510(k)	Class II	Active

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Spineology Inc. has one recall record initiated on September 16, 2024. The recall is listed with both open and classified statuses. The reason provided is a potential detachment of the Graft Tube shaft from the Graft Tube funnel head when not used according to the specified surgical instructions.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Sep 16, 2024	Z-0117-2025	—	open, classified	Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.