Z-Clamp ISP System— 510(k) K161016

Substantially Equivalent

Zavation, LLC

FDA 510(k) clearance K161016 for Z-Clamp ISP System, Substantially Equivalent on 2016-10-19. Applicant: Zavation, LLC. Device class: 2.

Clearance details

Applicant: Zavation, LLC
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2016-04-11
Decision date: 2016-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flowood, MS, 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.