510(k) K133039— RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

Substantially Equivalent

Mako Surgical Corporation

Clearance details

Applicant: Mako Surgical Corporation
Product code: Code NPJ
Advisory panel: Orthopedic
Date received: 2013-09-26
Decision date: 2013-12-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Fort Lauderdale, FL, US

Adverse events under product code NPJ

product code NPJ

Injury: 258
Total: 258

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.