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Fortilink Cages with TiPlus Technology

by Paradigm Spine GmbH

510(k) K201453

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201453↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK201453 Date7 Oct 2020ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
MAX
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Fortilink Cages with TiPlus Technology are interbody fusion devices manufactured with selective laser melting from implant grade titanium alloy (Ti6Al4V). These devices feature an open mesh structure and a bone window designed to allow bone growth.

The Fortilink Cages with TiPlus Technology are supplied as sterile devices and are intended for use in the cervical spine (C2-T1) for patients with degenerative disc diseases. The device has FDA 510(k) clearance with product code MAX and is classified as an Intervertebral Fusion Device With Bone Graft, Lumbar under Class II - Special Controls.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Fortilink Cages with TiPlus Technology used for?

    The Fortilink Cages with TiPlus Technology are interbody fusion devices intended for use in the cervical spine (C2-T1) for patients with degenerative disc diseases. They feature an open mesh structure and bone window to allow bone growth.

  • How are the Fortilink Cages supplied?

    The Fortilink Cages with TiPlus Technology are supplied as sterile devices. They are manufactured from implant grade titanium alloy (Ti6Al4V) using selective laser melting technology.

  • What sizes and models of Fortilink Cages are available?

    The device data does not specify available sizes or models. The Fortilink Cages with TiPlus Technology are designed for cervical spine fusion (C2-T1) but specific sizing options are not detailed in the provided information.

  • What is the regulatory status of the Fortilink Cages?

    The Fortilink Cages with TiPlus Technology has FDA 510(k) clearance with product code MAX and is classified as an Intervertebral Fusion Device With Bone Graft, Lumbar under Class II - Special Controls. It also has MDR authorization.