Cleared Traditional

OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design

K203465 · OSSIO , Ltd. · Orthopedic

Jan 2021

Decision

43d

Days

Class 2

Risk

About This 510(k) Submission

K203465 is an FDA 510(k) clearance for the OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by OSSIO , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on January 6, 2021, 43 days after receiving the submission on November 24, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K203465 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 24, 2020
Decision Date	January 06, 2021
Days to Decision	43 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF