Cleared Traditional

OSSIOfiber? Compression Staple

K233302 · OSSIO , Ltd. · Orthopedic

Nov 2023

Decision

48d

Days

Class 2

Risk

About This 510(k) Submission

K233302 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 November 16, 2023, 48 days after receiving the submission on September 29, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K233302 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2023
Decision Date	November 16, 2023
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF