NILE Proximal Fixation Spinal System— 510(k) K161332

Substantially Equivalent

K2m, Inc.

FDA 510(k) clearance K161332 for NILE Proximal Fixation Spinal System, Substantially Equivalent on 2017-04-05. 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: 2016-05-12
Decision date: 2017-04-05
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.