MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM— 510(k) K080029

Name: FDA 510(k) clearance K080029
Creator: U.S. Food and Drug Administration
Published: 2008-05-16

Substantially Equivalent

Mako Surgical Corp.

FDA 510(k) clearance K080029 for MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM, Substantially Equivalent on 2008-05-16. Applicant: Mako Surgical Corp.. Device class: 2.

Clearance details

Applicant: Mako Surgical Corp.
Product code: Code KRR
Device class: Class 2
Regulation: 21 CFR 888.3540
Advisory panel: Orthopedic
Date received: 2008-01-04
Decision date: 2008-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ft. Lauderdale, FL, 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.