Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers— 510(k) K172587

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K172587 for Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers, Substantially Equivalent on 2017-09-18. Applicant: Medacta International S.A..

Clearance details

Applicant: Medacta International S.A.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2017-08-28
Decision date: 2017-09-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Castel San Pietro (Ch), CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.