NILE Alternative Fixation Spinal System— 510(k) K160208

Substantially Equivalent

K2m, Inc.

FDA 510(k) clearance K160208 for NILE Alternative Fixation Spinal System, Substantially Equivalent on 2016-03-18. Applicant: K2m, Inc..

Clearance details

Applicant: K2m, Inc.
Product code: Code OWI
Advisory panel: Orthopedic
Date received: 2016-01-28
Decision date: 2016-03-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Leesburg, VA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.