RESTORIS POROUS PARTIAL KNEE SYSTEM— 510(k) K133811

Name: FDA 510(k) clearance K133811
Creator: U.S. Food and Drug Administration
Published: 2014-07-08

Substantially Equivalent

Mako Surgical Corp.

FDA 510(k) clearance K133811 for RESTORIS POROUS PARTIAL KNEE SYSTEM, Substantially Equivalent on 2014-07-08. Applicant: Mako Surgical Corp.. Device class: 2.

Clearance details

Applicant: Mako Surgical Corp.
Product code: Code NJD
Device class: Class 2
Regulation: 21 CFR 888.3535
Advisory panel: Orthopedic
Date received: 2013-12-16
Decision date: 2014-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.