Mako Total Hip Application, Mako Total Knee Application— 510(k) K191998

Substantially Equivalent

Mako Surgical Corp.

FDA 510(k) clearance K191998 for Mako Total Hip Application, Mako Total Knee Application, Substantially Equivalent on 2019-09-24. Applicant: Mako Surgical Corp..

Clearance details

Applicant: Mako Surgical Corp.
Product code: Code OLO
Advisory panel: Neurology
Date received: 2019-07-26
Decision date: 2019-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OLO

product code OLO

Death: 11
Injury: 2,799
Malfunction: 11,105
Other: 1
Total: 13,916

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.