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FDA 510(k)

Fortilink Cages with TiPlus Technology

K-Number: K201453 · 2020-10-07

ApplicantParadigm Spine GmbH
Decision Date2020-10-07
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fortilink Cages with TiPlus Technology is a medical device manufactured by Paradigm Spine GmbH. It received FDA 510(k) clearance on 2020-10-07 under approval number K201453. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fortilink Cages with TiPlus Technology?

Fortilink Cages with TiPlus Technology is a medical device that received FDA 510(k) clearance on 2020-10-07. It is manufactured by Paradigm Spine GmbH. The 510(k) number is K201453.

When was Fortilink Cages with TiPlus Technology approved by the FDA?

Fortilink Cages with TiPlus Technology received FDA 510(k) clearance on 2020-10-07, under approval number K201453.

What company makes Fortilink Cages with TiPlus Technology?

Fortilink Cages with TiPlus Technology is manufactured by Paradigm Spine GmbH.

What is the FDA product code for Fortilink Cages with TiPlus Technology?

The FDA product code for Fortilink Cages with TiPlus Technology is MAX.

Related Clinical Trials

NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Other Devices by Paradigm Spine GmbH

K201704CoFix System

Related Devices (Code: MAX)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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