Facility

SPINEOLOGY INC.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

4inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3003179719
Establishment type	Manufacture Medical Device
Location	7800 THIRD STREET N. Saint Paul, MN, US 55128
Registration status	Active · expires 2026
Parent company	Spineology Inc (owner-operator 9036813)
Brand names	OptiMesh

Activity by year

Recalls (1)
Inspections (4)

Devices registered here (1)

Mesh, Surgical, Metal
Product code EZX (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.3300

Recalls & enforcement

Class IIOngoing2024-09-16
Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.

FDA inspections (4)

NAI2025-04-17
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2022-02-15
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2018-10-12
No Action Indicated · Bioresearch Monitoring
VAI2017-03-31
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Spineology Inc

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SPINEOLOGY INC. (FEI 3003179719) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003179719-spineology-inc/

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