RESTORIS Multicompartmental Knee System— 510(k) K150307

Substantially Equivalent

Mako Surgical Corp.

FDA 510(k) clearance K150307 for RESTORIS Multicompartmental Knee System, Substantially Equivalent on 2015-03-10. Applicant: Mako Surgical Corp..

Clearance details

Applicant: Mako Surgical Corp.
Product code: Code NPJ
Advisory panel: Orthopedic
Date received: 2015-02-09
Decision date: 2015-03-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Fort Lauderdale, FL, US

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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.