Cleared Traditional

A?TOMIC? Nitinol Fixation System

K232990 · Rmr Ortho, LLC · Orthopedic

Jan 2024

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K232990 is an FDA 510(k) clearance for the A?TOMIC? Nitinol Fixation System, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Rmr Ortho, LLC (Castroville, US). The FDA issued a Cleared decision on January 12, 2024, 112 days after receiving the submission on September 22, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K232990 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 2023
Decision Date	January 12, 2024
Days to Decision	112 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF