MITEK ARTHROSCOPES— 510(k) K133941

Name: FDA 510(k) clearance K133941
Creator: U.S. Food and Drug Administration
Published: 2014-04-18

Substantially Equivalent

Medos International SARL

FDA 510(k) clearance K133941 for MITEK ARTHROSCOPES, Substantially Equivalent on 2014-04-18. Applicant: Medos International SARL. Device class: 2.

Clearance details

Applicant: Medos International SARL
Product code: Code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 2013-12-23
Decision date: 2014-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Le Locle, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRX

view all

K260203 — Fule Vertebroplasty Balloon Catheter2026-08-28
K254103 — HOPKINS Telescopes for Arthroscopy2026-08-26
K252790 — Digital ClarusScope System and Digital NeuroPEN System2026-05-26
K253523 — Freedom DS Decompression System2026-04-16
K252546 — VantageTM Lumbar Decompression Kit2026-03-12

More clearances from Medos International SARL

view all

K254157 — CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody2026-05-26
K260240 — SYMPHONY Navigation Ready Instruments2026-03-27
K253249 — TriALTIS Spine System2025-10-21
K243249 — TriALTIS Spine System2025-01-17
K241893 — CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays2024-09-16

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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