Nile Alternative Fixation— 510(k) K143350

Substantially Equivalent

K2m, Inc.

FDA 510(k) clearance K143350 for Nile Alternative Fixation, Substantially Equivalent on 2015-02-25. Applicant: K2m, Inc.. Device class: 2.

Clearance details

Applicant: K2m, Inc.
Product code: Code OWI
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 2014-11-24
Decision date: 2015-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leesburg, VA, 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.