MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES— 510(k) K131559

Substantially Equivalent

Materialise NV

FDA 510(k) clearance K131559 for MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES, Substantially Equivalent on 2013-09-27. Applicant: Materialise NV.

Clearance details

Applicant: Materialise NV
Product code: Code KWS
Advisory panel: Orthopedic
Date received: 2013-05-30
Decision date: 2013-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWS

product code KWS

Death: 6
Injury: 9,652
Malfunction: 1,385
Other: 1
Total: 11,044

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.