Cleared Traditional

OSSIOfiber? Staple

K212594 · OSSIO , Ltd. · Orthopedic
Jan 2022
Decision
158d
Days
Class 2
Risk

About This 510(k) Submission

K212594 is an FDA 510(k) clearance for the OSSIOfiber? Staple, a Staple, Absorbable (Class II — Special Controls, product code MNU), submitted by OSSIO , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on January 21, 2022, 158 days after receiving the submission on August 16, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K212594 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 2021
Decision Date January 21, 2022
Days to Decision 158 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MNU — Staple, Absorbable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030