Chrysalis Intelligence · Sponsors · Spineology, Inc.

Spineology, Inc.

Saint Paul, MN, US · 7 510(k) clearances · 1 recalls

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals

Total clearances

7

2020-09-18 → 2025-12-15

Last 12 months

2

Product codes

3

Most recent

2025-12-15

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
OQB	Intervertebral Body Graft Containment Device	Class II	Orthopedic	4	2025-12-15
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	2	2025-12-04
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Class II	Orthopedic	1	2021-02-19

Safety

Recalls (1)

Class I (serious)

0

Risk of injury / death

Total recalls

1

Currently ongoing

1

Most recent

2024-09-16

Date	Severity	Status	Recall #	Product	Code	Reason
2024-09-16	Class II	Ongoing	Z-0117-2025	The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced t…	—	Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.

Filings

All 510(k) clearances (7)

Date	K-number	Device	Code	Class	Specialty
2025-12-15	K251302	OptiMesh Multiplanar Expandable Interbody Fusion System	OQB	Class II	Orthopedic
2025-12-04	K251943	Spineology Navigation Instruments	OLO	Class II	Neurology
2023-11-01	K230927	OptiMesh Multiplanar Expandable Interbody Fusion System	OQB	Class II	Orthopedic
2023-10-18	K231781	OptiMesh Multiplanar Expandable Interbody Fusion System	OQB	Class II	Orthopedic
2022-08-05	K213876	Spineology Navigation Instruments	OLO	Class II	Neurology
2021-02-19	K210155	Duo Expandable Interbody Fusion System	MAX	Class II	Orthopedic
2020-09-18	DEN200010	Spineology Interbody Fusion System	OQB	Class II	Orthopedic