Cleared Traditional

OSSIOfiber Suture Anchor

K213415 · OSSIO , Ltd. · Orthopedic
Mar 2022
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K213415 is an FDA 510(k) clearance for the OSSIOfiber Suture Anchor, 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 March 28, 2022, 160 days after receiving the submission on October 19, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K213415 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 2021
Decision Date March 28, 2022
Days to Decision 160 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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