Facility

CAPTIVA SPINE, Inc.

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

Key facts

2recalls · worst Class II

2inspections · 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)	3006082533
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	967 N HIGHWAY A1A ALT STE 1 Jupiter, FL, US 33477
Registration status	Active · expires 2026
Parent company	CAPTIVA SPINE (owner-operator 9096708)
Brand names	TirboLOX-L Lumbar IBFD

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (1)

Intervertebral Fusion Device With Bone Graft, Lumbar
Product code MAX (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3080

Recalls & enforcement

Class IITerminated2015-02-25
It is possible for the titanium color-coded ring to detach from the Reamers.
Class IITerminated2012-09-20
Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking

FDA inspections (2)

NAI2025-01-14
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2017-02-17
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 CAPTIVA SPINE

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. “CAPTIVA SPINE, Inc. (FEI 3006082533) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006082533-captiva-spine-inc/

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