MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II— 510(k) K082088

Name: FDA 510(k) clearance K082088
Creator: U.S. Food and Drug Administration
Published: 2008-10-22

Substantially Equivalent

Mako Surgical Corp.

FDA 510(k) clearance K082088 for MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II, Substantially Equivalent on 2008-10-22. 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: 2008-07-24
Decision date: 2008-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort 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.