OSSIOfiber® Compression Staple— 510(k) K233302

Substantially Equivalent

OSSIO , Ltd.

FDA 510(k) clearance K233302 for OSSIOfiber® Compression Staple, Substantially Equivalent on 2023-11-16. Applicant: OSSIO , Ltd.. Device class: 2.

Clearance details

Applicant: OSSIO , Ltd.
Product code: Code MNU
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2023-09-29
Decision date: 2023-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNU

K241932 — OSSIOfiber® Compression Staple2024-08-28
K212594 — OSSIOfiber® Staple2022-01-21
K011172 — ARTHREX BIO-TRANSFIX2001-06-19

More clearances from OSSIO , Ltd.

K254077 — OSSIOfiber® Threaded Trimmable Fixation Nail2026-05-01
K254055 — OSSIOfiber® Suture Anchor2026-02-24
K252022 — OSSIOfiber® Interference Screw2025-08-19
K251309 — OSSIOfiber® Suture Anchor2025-05-27
K243760 — OSSIOfiber® Suture Anchor 2.5-3.5 mm2025-04-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.