Fortilink with TiPlus Technology

Q: What is the product code of K213493?

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

FDA 510(k) K213493 · Paradigm Spine

Substantially Equivalent

510(k) numberK213493

Submission

Device name: Fortilink with TiPlus Technology
Applicant: Paradigm Spine
Wurmlingen Baden-Wurttemberg, DE
Received: November 1, 2021
Decision date: January 27, 2022
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

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

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

Other 510(k)s with product code ODP

510(k)	Device	Applicant	Decision
K262595	VariLift-C Cervical Interbody Fusion SystemODP · Special	Wenzel Spine, Inc.	08/26/2026SE
K262489	BluEX Cervical Expandable Cage SystemODP · Special	L&K BIOMED Co., Ltd.	08/18/2026SE
K253041	3d Cage CervicalODP · Traditional	Fims Co., Ltd.	07/23/2026SE
K262061	Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…ODP · Special	Stryker Spine	07/17/2026SE
K254130	C.A. Medical Interbody Fusion SystemODP · Special	C.A. Medical, LLC	07/08/2026SE
K260840	BluEX Cervical Expandable Cage SystemODP · Traditional	L&K BIOMED Co., Ltd.	05/16/2026SE
K260850	Osteomni Spinal Cages SystemODP · Traditional	Osteomni, Inc.	05/12/2026SE
K260549	ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemODP · Special	Zsfab, Inc.	04/24/2026SE
K253260	ORIO-3D Cage SystemODP · Traditional	SpineCraft	04/16/2026SE
K260340	HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC…ODP · Traditional	HC Biologics, LLC	04/13/2026SE

More from HC Biologics, LLC

510(k)	Device	Decision
K201453	Fortilink Cages with TiPlus TechnologyMAX · Traditional	10/07/2020SE
K201704	CoFix SystemPEK · Special	08/04/2020SE
K153302	coflex-IFPEK · Traditional	09/08/2016SE
K120491	DSS Stabilization System-RigidMNH · Traditional	05/09/2012SESU
K112595	Coflex-FKWP · Traditional	02/13/2012SE
K113625	DSS Stabilization SystemNKB · Special	01/10/2012SESU
K093438	Paradigm Interspinous Fusion PlateKWP · Traditional	10/06/2010SE
K101083	DSS Stabilization SystemNQP · Special	07/02/2010SESU
K091944	Modification to: DSS Stabilization SystemNQP · Special	08/03/2009SE
K090099	DSS Stabilization SystemNKB · Traditional	06/19/2009SESU

Questions and answers

When was Fortilink with TiPlus Technology cleared by the FDA?

Fortilink with TiPlus Technology (K213493) received a 510(k) decision of Substantially Equivalent on January 27, 2022, 87 days after the submission was received.

What is the product code of K213493?

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