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FDA Product Code

FDA Product Code MNU — Clearance Directory

Device Class
Class II
Assigned Panel
Orthopedic
21 CFR Citation
888.3030

510(k) Clearances — 4 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K241932 OSSIOfiber® Compression Staple OSSIO , Ltd. 2024-08-28 Traditional PDF ↗
K233302 OSSIOfiber® Compression Staple OSSIO , Ltd. 2023-11-16 Traditional PDF ↗
K212594 OSSIOfiber® Staple OSSIO , Ltd. 2022-01-21 Traditional PDF ↗
K011172 ARTHREX BIO-TRANSFIX Arthrex, Inc. 2001-06-19 Traditional PDF ↗

Product code MNU · Class II · Orthopedic. Data: openFDA.