HIP SEXTANT INSTRUMENT SYSTEM— 510(k) K093491

Name: FDA 510(k) clearance K093491
Creator: U.S. Food and Drug Administration
Published: 2010-12-09

Substantially Equivalent

Surgical Planning Associates

FDA 510(k) clearance K093491 for HIP SEXTANT INSTRUMENT SYSTEM, Substantially Equivalent on 2010-12-09. Applicant: Surgical Planning Associates. Device class: 2.

Clearance details

Applicant: Surgical Planning Associates
Product code: Code OSF
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2009-11-10
Decision date: 2010-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medford, MA, US

Download summary PDF View on FDA.gov ↗

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