Cleared Traditional

OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm

K221193 · OSSIO , Ltd. · Orthopedic
Dec 2022
Decision
242d
Days
Class 2
Risk

About This 510(k) Submission

K221193 is an FDA 510(k) clearance for the OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm, 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 23, 2022, 242 days after receiving the submission on April 25, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K221193 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2022
Decision Date December 23, 2022
Days to Decision 242 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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