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.
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...
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.
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.