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FDA 510(k)

Femoral Trochanteric Nail System – Neonail

K-Number: K221021 · 2022-12-06

ApplicantNeoortho Produtos Ortopédicos S/A
Decision Date2022-12-06
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Femoral Trochanteric Nail System – Neonail is a medical device manufactured by Neoortho Produtos Ortopédicos S/A. It received FDA 510(k) clearance on 2022-12-06 under approval number K221021. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Femoral Trochanteric Nail System – Neonail?

Femoral Trochanteric Nail System – Neonail is a medical device that received FDA 510(k) clearance on 2022-12-06. It is manufactured by Neoortho Produtos Ortopédicos S/A. The 510(k) number is K221021.

When was Femoral Trochanteric Nail System – Neonail approved by the FDA?

Femoral Trochanteric Nail System – Neonail received FDA 510(k) clearance on 2022-12-06, under approval number K221021.

What company makes Femoral Trochanteric Nail System – Neonail?

Femoral Trochanteric Nail System – Neonail is manufactured by Neoortho Produtos Ortopédicos S/A.

What is the FDA product code for Femoral Trochanteric Nail System – Neonail?

The FDA product code for Femoral Trochanteric Nail System – Neonail is HSB.

Related Clinical Trials

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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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