RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM— 510(k) K112507

Substantially Equivalent

Mako Surgical Corporation

FDA 510(k) clearance K112507 for RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM, Substantially Equivalent on 2012-03-01. Applicant: Mako Surgical Corporation.

Clearance details

Applicant: Mako Surgical Corporation
Product code: Code OLO
Advisory panel: Neurology
Date received: 2011-08-30
Decision date: 2012-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Lauderdale, FL, US

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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.