HEALIX ADVANCE SP BIOCOMPOSITE Anchor— 510(k) K191242

Substantially Equivalent

Medos International SARL

FDA 510(k) clearance K191242 for HEALIX ADVANCE SP BIOCOMPOSITE Anchor, Substantially Equivalent on 2019-08-22. Applicant: Medos International SARL.

Clearance details

Applicant: Medos International SARL
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2019-05-09
Decision date: 2019-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Le Locle, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

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.