Regulatory Clearances for K2M’s NILE Proximal Fixation System

By Julie A. Vetalice

K2M received FDA 510(k) clearance and CE Mark approval for the NILE® Proximal Fixation system for complex spinal deformity.

The system comprises bands and connectors for use with rod constructs. The CE Mark also includes the use of anchors, which are not cleared in the U.S.

NILE's polyethylene terephthalate bands can provide additional fixation in MESA®, MESA 2, EVEREST® or DENALI® constructs through sublaminar passage or attachment to an anchor (the latter, ex-U.S. only).

Source: K2M, Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory