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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 39 of 40

Device	Model / Reference	Registries	Class	Status
SOAR Retractor System	78-02-02-3	FDA UDI	Class I	Active
Threshold Pedicle Screw	10-10-09-26	FDA UDI	Class II	Active
Threshold Solid Pedicle Screw	10-10-80-25	FDA UDI	Class II	Unknown
Merlon Retractor System	19-01-09-02	FDA UDI	Class I	Active
Threshold Fixed Perc Rod	10-10-07-5	FDA UDI	Class II	Active
Duo Ti Expandable Interbody Fusion System	86-12-03-7	FDA UDI	Class II	Active
Duo Ti Expandable Interbody Fusion System	86-12-02-16	FDA UDI	Class II	Active
Discectomy Set	15-02-04-11	FDA UDI	Class I	Active
Threshold Solid Pedicle Screw	10-10-78-6	FDA UDI	Class II	Active
SOAR Retractor System	78-03-02-8	FDA UDI	Class I	Active
Threshold Solid Pedicle Screw	10-10-80-23	FDA UDI	Class II	Unknown
Duo Ti Expandable Interbody Fusion System	86-06-38	FDA UDI	Class I	Active
Threshold Solid Pedicle Screw	10-10-80-22	FDA UDI	Class II	Unknown
Duo Ti Expandable Interbody Fusion System	86-11-21-12	FDA UDI	Class II	Active
Duo Ti Expandable Interbody Fusion System	86-12-01-15	FDA UDI	Class II	Active
Fortress Rod	10-10-51-3	FDA UDI	Class II	Active
Threshold Solid Pedicle Screw	10-10-80-33	FDA UDI	Class II	Unknown
Medius Midline Retractor System	66-02-01-38	FDA UDI	Class I	Active
Medius Midline Retractor System	66-02-01-24	FDA UDI	Class I	Active
Duo Ti Expandable Interbody Fusion System	86-12-02-1	FDA UDI	Class II	Active
Threshold Pedicle Screw	10-10-10-03	FDA UDI	Class II	Active
Threshold Solid Pedicle Screw	10-10-80-21	FDA UDI	Class II	Unknown
Duo Ti Expandable Interbody Fusion System	86-06-23	FDA UDI	Class I	Active
Duo Ti Expandable Interbody Fusion System	86-12-01-16	FDA UDI	Class II	Active
Duo Ti Expandable Interbody Fusion System	86-05-85	FDA UDI	Class I	Active
Threshold Curved Rod	10-10-07-23	FDA UDI	Class II	Active
Merlon Retractor System	19-01-04-04	FDA UDI	Class I	Active
Fortress Rod	10-10-48-48	FDA UDI	Class II	Active
Duo Ti Expandable Interbody Fusion System	86-11-06	FDA UDI	Class I	Active
Threshold Solid Pedicle Screw	10-10-79-3	FDA UDI	Class II	Active
SOAR Retractor System	78-02-45-9	FDA UDI	Class I	Active
OptiLIF Endo, Direct Visualization System	05-01-24-3	FDA UDI	Class I	Active
Duo Ti Expandable Interbody Fusion System	102-42-01	FDA UDI	Class II	Active
Duo Ti Expandable Interbody Fusion System	86-11-18-10	FDA UDI	Class II	Active
Universal Dilator	52-03-12	FDA UDI	Class I	Active
Threshold Articulating Perc Rod	10-10-07-20	FDA UDI	Class II	Active
SOAR Retractor System	78-02-45-4	FDA UDI	Class I	Active
Verify	10-01-80	FDA UDI	Class I	Active
Discectomy Set	10-01-140	FDA UDI	Class I	Active
Threshold Solid Pedicle Screw	10-10-80-27	FDA UDI	Class II	Unknown
Duo Ti Expandable Interbody Fusion System	86-06-09	FDA UDI	Class I	Active
Duo Lumbar Interbody Fusion Device	K190055	FDA 510(k)	Class II	Active
OptiMesh Multiplanar Expandable Interbody Fusion System	K251302	FDA 510(k)	Class II	Active
Optimesh 500e Cement Restrictor	K033953	FDA 510(k)	Class II	Active
OptiMesh Multiplanar Expandable Interbody Fusion System	K231781	FDA 510(k)	Class II	Active
Rampart-O, Rampart-T	K132053	FDA 510(k)	Class II	Active
Spineology Navigation Instruments	K172518	FDA 510(k)	Class II	Active
K-Centrum Anterior Spinal Fixation System	K990959	FDA 510(k)	Class II	Active
Rampart-L	K133371	FDA 510(k)	Class II	Active
Spineology Interbody Fusion System	DEN200010	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.