Cleared Traditional

K201147 - Elos® Intramedullary Nailing System (FDA 510(k) Clearance)

K201147 · Intrauma S.P.A · Orthopedic device

Jul 2021

Decision

446d

Days

Class 2

Risk

K201147 is an FDA 510(k) clearance for the Elos® Intramedullary Nailing System. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).

Submitted by Intrauma S.P.A (Rivoli (To), IT). The FDA issued a Cleared decision on July 19, 2021, 446 days after receiving the submission on April 29, 2020.

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

Submission Details

510(k) Number	K201147 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 29, 2020
Decision Date	July 19, 2021
Days to Decision	446 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF