TirboLOX-L Lumbar IBFD

Q: What is the product code of K180990?

The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.

FDA 510(k) K180990 · Captiva Spine, Inc.

Substantially Equivalent

510(k) numberK180990

Submission

Device name: TirboLOX-L Lumbar IBFD
Applicant: Captiva Spine, Inc.
Jupiter, FL, US
Received: April 16, 2018
Decision date: August 13, 2018
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3080
Specialty: Orthopedic
Implant: Yes

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other 510(k)s with product code MAX

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K261020	Symmetrix L Spinal SystemMAX · Traditional	Medtronic Sofamor Danek USA, Inc.	07/14/2026SE
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K261159	Exceed® Biplanar Expandable Interbody SystemMAX · Traditional	Spine Wave, Inc.	05/29/2026SE
K253894	BMD Titanium Spinal Fusion SystemMAX · Traditional	Global Biomedica s.r.o.	05/28/2026SE
K260506	Ventana® P/T Lumbar Interbody SystemMAX · Traditional	Spinal Elements, Inc.	05/15/2026SE
K260837	VersaLift Expandable SystemMAX · Traditional	Life Spine, Inc.	05/12/2026SE

More from Life Spine, Inc.

510(k)	Device	Decision
K193270	CapLOX II®/TowerLOX® MIS Pedicle Screw SystemNKB · Special	01/31/2020SE
K181229	TirboLOX-C Cervical IBFDODP · Traditional	09/19/2018SE
K180475	CapLOX II® / TowerLOX® MIS Pedicle Screw SystemNKB · Traditional	03/19/2018SE
K160020	Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special	03/02/2016SE
K151116	CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special	06/26/2015SE
K141332	Captiva Spine SmartLOX Cervical Plate SystemKWQ · Traditional	06/11/2015SE
K142586	Captiva Spine FuselOX Cervical IBF SystemODP · Traditional	05/28/2015SE
K131538	Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemMNH · Special	08/08/2013SE
K122956	Fuselox Lumbar Interbody Fusion DeviceMAX · Special	10/25/2012SE
K122332	Towerlox Pedicle Screw SystemMNI · Special	10/16/2012SE

Questions and answers

When was TirboLOX-L Lumbar IBFD cleared by the FDA?

TirboLOX-L Lumbar IBFD (K180990) received a 510(k) decision of Substantially Equivalent on August 13, 2018, 119 days after the submission was received.

What is the product code of K180990?

The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.