Cleared Traditional

OSSIOfiber? Pin Product Family, OSSIOfiber? Compression Screw, OSSIOfiber? Trimmable Fixation Nail

K231272 · OSSIO , Ltd. · Orthopedic

Dec 2023

Decision

213d

Days

Class 2

Risk

About This 510(k) Submission

K231272 is an FDA 510(k) clearance for the OSSIOfiber? Pin Product Family, OSSIOfiber? Compression Screw, OSSIOfiber? Trimmable Fixation Nail, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by OSSIO , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on December 1, 2023, 213 days after receiving the submission on May 2, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K231272 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 2023
Decision Date	December 01, 2023
Days to Decision	213 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF