Facility

SpineNet LLC

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

Key facts

2recalls · worst Class II

3inspections · 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)	3006755626
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	901 N. Lake Destiny Rd Maitland, FL, US 32751
Registration status	Active · expires 2026
Parent company	SpineNet (owner-operator 10022679)
Brand names	SpineNet SSP

Activity by year

Recalls (2)
Inspections (3)

Devices registered here (1)

Appliance, Fixation, Spinal Intervertebral Body
Product code KWQ (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3060

Recalls & enforcement

Class IITerminated2013-02-05
The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to initial product marketing.
Class IITerminated2013-02-04
SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.

FDA inspections (3)

NAI2024-04-19
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2019-10-09
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2016-10-04
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

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 SpineNet

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. “SpineNet LLC (FEI 3006755626) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006755626-spinenet-llc/

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