Cleared Traditional

K221021 - Femoral Trochanteric Nail System – Neonail (FDA 510(k) Clearance)

K221021 · Neoortho Produtos Ortop?dicos S/A · Orthopedic device

Dec 2022

Decision

244d

Days

Class 2

Risk

K221021 is an FDA 510(k) clearance for the Femoral Trochanteric Nail System – Neonail. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).

Submitted by Neoortho Produtos Ortop?dicos S/A (Curitiba, BR). The FDA issued a Cleared decision on December 6, 2022, 244 days after receiving the submission on April 6, 2022.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number	K221021 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 06, 2022
Decision Date	December 06, 2022
Days to Decision	244 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF