Who is the manufacturer of STAXX(R) XD SYSTEM?

Spine Wave, Inc. submitted the Special clearance for STAXX(R) XD SYSTEM (K102682).

What is the FDA product code for STAXX(R) XD SYSTEM?

MQP. It is classified under 21 CFR 888.3060 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for STAXX(R) XD SYSTEM?

510(k) clearance (submission type: Special).

STAXX(R) XD SYSTEM

K102682 · Spine Wave, Inc. · MQP · Nov 30, 2010 · Orthopedic

Device Facts

Record ID	K102682
Device Name	STAXX(R) XD SYSTEM
Applicant	Spine Wave, Inc.
Product Code	MQP · Orthopedic
Decision Date	Nov 30, 2010
Decision	SESE
Submission Type	Special
Regulation	21 CFR 888.3060
Device Class	Class 2

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.