Cleared Traditional

OSSIOfiber? Hammertoe Fixation System/OSSIOfiber? Hammertoe Fixation Implant

K190652 · OSSIO , Ltd. · Orthopedic

Mar 2020

Decision

359d

Days

Class 2

Risk

About This 510(k) Submission

K190652 is an FDA 510(k) clearance for the OSSIOfiber? Hammertoe Fixation System/OSSIOfiber? Hammertoe Fixation Implant, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by OSSIO , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on March 6, 2020, 359 days after receiving the submission on March 13, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K190652 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 2019
Decision Date	March 06, 2020
Days to Decision	359 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF