Facility

SPINE WAVE, INC.

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)	3004638600
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	THREE ENTERPRISE DR. SHELTON, CT, US 06484
Registration status	Active · expires 2026
Parent company	SPINE WAVE, INC. (owner-operator 9055730)
Brand names	CAPSURE PS SPINE SYSTEM

Activity by year

Recalls (2)
Inspections (3)

Devices registered here (2)

Orthosis, Spondylolisthesis Spinal Fixation
Product code MNH (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3070
Orthosis, Spinal Pedicle Fixation
Product code MNI (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3070

Recalls & enforcement

Class IITerminated2015-05-04
Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm
Class IITerminated2013-05-14
A component Superior endplate manufactured from a different polymer than specified

FDA inspections (3)

NAI2026-04-21
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2023-04-25
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2017-01-10
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 SPINE WAVE, 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. “SPINE WAVE, INC. (FEI 3004638600) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004638600-spine-wave-inc/

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