Cleared Traditional

OSSIOfiber? Compression Staple

K241932 · OSSIO , Ltd. · Orthopedic
Aug 2024
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K241932 is an FDA 510(k) clearance for the OSSIOfiber? Compression Staple, a Staple, Absorbable (Class II — Special Controls, product code MNU), submitted by OSSIO , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on August 28, 2024, 58 days after receiving the submission on July 1, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K241932 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2024
Decision Date August 28, 2024
Days to Decision 58 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