FDA 510(k)

Fortilink with TiPlus Technology

Número K: K213493 · 2022-01-27

Data da decisão2022-01-27

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Paradigm Spine. The 510(k) number is K213493.

When did Fortilink with TiPlus Technology receive FDA 510(k) clearance?

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

Who is the listed applicant for Fortilink with TiPlus Technology?

The FDA 510(k) record lists Paradigm Spine as the applicant. This does not by itself establish the device manufacturer.

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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