FDA 510(k)

Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System

Número K: K261284 · 2026-07-14

Data da decisão2026-07-14

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2026-07-14 under 510(k) number K261284. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System?

Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2026-07-14. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K261284.

When did Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System receive FDA 510(k) clearance?

Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System received FDA 510(k) clearance on 2026-07-14, under 510(k) number K261284.

Who is the listed applicant for Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System?

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

What is the FDA product code for Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System?

The FDA product code for Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System is NKB.

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Fonte oficial

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