HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture— 510(k) K203794

Substantially Equivalent

Medos International SARL

FDA 510(k) clearance K203794 for HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture, Substantially Equivalent on 2021-02-01. Applicant: Medos International SARL.

Clearance details

Applicant: Medos International SARL
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2020-12-28
Decision date: 2021-02-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Le Locle, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.