FDA 510(k)

Fortilink with TiPlus Technology

K-Number: K213493 · 2022-01-27

Decision Date2022-01-27

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Fortilink with TiPlus Technology is a medical device manufactured by Paradigm Spine. It received FDA 510(k) clearance on 2022-01-27 under approval number K213493. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fortilink with TiPlus Technology?

Fortilink with TiPlus Technology is a medical device that received FDA 510(k) clearance on 2022-01-27. It is manufactured by Paradigm Spine. The 510(k) number is K213493.

When was Fortilink with TiPlus Technology approved by the FDA?

Fortilink with TiPlus Technology received FDA 510(k) clearance on 2022-01-27, under approval number K213493.

What company makes Fortilink with TiPlus Technology?

Fortilink with TiPlus Technology is manufactured by Paradigm Spine.

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

The FDA product code for Fortilink with TiPlus Technology is ODP.

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Official Source

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