Who is the manufacturer of SCS DT-02 TRANSVERSE CONNECTOR?

Ortho Tec, LLC submitted the Special clearance for SCS DT-02 TRANSVERSE CONNECTOR (K003823).

What is the FDA product code for SCS DT-02 TRANSVERSE CONNECTOR?

KWP. It is classified under 21 CFR 888.3050 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for SCS DT-02 TRANSVERSE CONNECTOR?

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

SCS DT-02 TRANSVERSE CONNECTOR

K003823 · Ortho Tec, LLC · KWP · Jul 11, 2001 · Orthopedic

Device Facts

Record ID	K003823
Device Name	SCS DT-02 TRANSVERSE CONNECTOR
Applicant	Ortho Tec, LLC
Product Code	KWP · Orthopedic
Decision Date	Jul 11, 2001
Decision	SESE
Submission Type	Special
Regulation	21 CFR 888.3050
Device Class	Class 2

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.