Cleared Traditional

OSSIOfiber Compression Screw, 3.5mm

K213596 · OSSIO , Ltd. · Orthopedic
Dec 2021
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K213596 is an FDA 510(k) clearance for the OSSIOfiber Compression Screw, 3.5mm, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by OSSIO , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on December 21, 2021, 39 days after receiving the submission on November 12, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K213596 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2021
Decision Date December 21, 2021
Days to Decision 39 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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