RESTORIS POROUS PARTIAL KNEE SYSTEM— 510(k) K150410

Substantially Equivalent

Mako Surgical Corporation

FDA 510(k) clearance K150410 for RESTORIS POROUS PARTIAL KNEE SYSTEM, Substantially Equivalent on 2015-03-20. Applicant: Mako Surgical Corporation.

Clearance details

Applicant: Mako Surgical Corporation
Product code: Code HRY
Advisory panel: Orthopedic
Date received: 2015-02-18
Decision date: 2015-03-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Fort Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRY

product code HRY

Injury: 1,551
Malfunction: 2,753
Total: 4,304

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.