Cleared Traditional

OSSIOfiber? Suture Anchor 2.5-3.5 mm

K243760 · OSSIO , Ltd. · Orthopedic
Apr 2025
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K243760 is an FDA 510(k) clearance for the OSSIOfiber? Suture Anchor 2.5-3.5 mm, a Fastener, Fixation, Biodegradable, Soft Tissue (Class II — Special Controls, product code MAI), submitted by OSSIO , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on April 3, 2025, 118 days after receiving the submission on December 6, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K243760 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2024
Decision Date April 03, 2025
Days to Decision 118 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MAI — Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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