Who is the manufacturer of CD HORIZON ANTERIOR SPINAL SYSTEM?

Sofamor Danek USA,Inc. filed the 510(k) submission for CD HORIZON ANTERIOR SPINAL SYSTEM (K963655).

What is the FDA product code for CD HORIZON ANTERIOR SPINAL SYSTEM?

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

What is the regulatory pathway for CD HORIZON ANTERIOR SPINAL SYSTEM?

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

Who can help prepare an FDA 510(k) submission like CD HORIZON ANTERIOR SPINAL SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CD HORIZON ANTERIOR SPINAL SYSTEM

K963655 · Sofamor Danek USA,Inc. · KWQ · Nov 27, 1996 · Orthopedic

Device Facts

Record ID	K963655
Device Name	CD HORIZON ANTERIOR SPINAL SYSTEM
Applicant	Sofamor Danek USA,Inc.
Product Code	KWQ · Orthopedic
Decision Date	Nov 27, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3060
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The CD HORIZON™ Anterior Spinal System is designed to aid in the surgical correction and stabilization of the spine. The system is intended to assist stabilization until a solid spinal fusion develops. The specific indications for the CD HORIZON™ Anterior Spinal System are the following: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). 2. Pseudoarthrosis 3. Stenosis 4. Spondylolisthesis 5. Spinal deformities: scoliosis, kyphosis, lordosis 6. Fracture 7. Unsuccessful previous attempts at spinal fusion 8. Tumor resection All components of the CD HORIZON™ Anterior Spinal System are intended to be fixed/attached to the anterolateral spine by screws/staples in the thoracic and/or lumbar areas only.

Device Story

System consists of rods, screws, set screws, and staples for anterolateral spinal fixation. Provides stabilization to facilitate solid spinal fusion. Used by surgeons in clinical settings. Components compatible with 5.5mm and 6.35mm rods (GDLH, TSRH, LIBERTY). Implants fixed to thoracic/lumbar spine via screws/staples. Benefits include structural support during bone healing.

Clinical Evidence

Bench testing only; mechanical test data supplied to support substantial equivalence.

Technological Characteristics

Components fabricated from ASTM F138 stainless steel (or ISO equivalent). System includes rods (5.5mm/6.35mm), screws, set screws, and staples. Sold sterile or non-sterile. Stainless steel components must not be mixed with titanium alloy in a single construct.

Indications for Use

Indicated for patients requiring spinal stabilization during fusion for degenerative disc disease, pseudoarthrosis, stenosis, spondylolisthesis, spinal deformities (scoliosis, kyphosis, lordosis), fractures, failed prior fusion, or tumor resection. For use in thoracic and/or lumbar spine via anterolateral approach.

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.

Related Devices

K091782 — REVERE 6.35 STABILIZATION SYSTEM · Globus Medical, Inc. · Aug 13, 2009
K965193 — LIBERTY ANTERIOR SPINAL SYSTEM · Sofamor Danek USA,Inc. · Mar 17, 1997
K042025 — MODIFICATION TO CD HORIZON SPINAL SYSTEM · Medtronic Sofamor Danek, Inc. · Aug 25, 2004
K041862 — CD HORIZON SPINAL SYSTEM · Medtronic Sofamor Danek · Sep 15, 2004
K061592 — MODIFICATION TO CD HORIZON SYSTEM · Medtronic Sofamor Danek, Inc. · Jul 3, 2006

Submission Summary (Full Text)

{0} NOV 19 '96 02:53PM SOFAMOR DANEK -14/14 # CD HORIZON™ Anterior Spinal System 510(k) Summary K963655 November, 1996 NOV 27 1996 I. Company: Sofamor Danek USA 1800 Pyramid Place Memphis, TN 38132 901-396-3133 II. Proprietary Trade Name: CD HORIZON™ Anterior Spinal System Classification Name: Spinal intervertebral body fixation orthosis. III. The CD HORIZON™ Anterior Spinal System consists of rods, screws, a set screw, and staples. In general, the system features implant components which can be used with either 5.5mm and 6.35mm Sofamor Danek rods. The 5.5mm GDLH™, 6.35mm TSRH®, and 6.35mm LIBERTY™ rods can be used with the CD HORIZON™ Anterior Spinal System. Instrumentation is also available to facilitate implantation of the device components. The purpose of the CD HORIZON™ Anterior Spinal System is to provide stabilization during the development of a solid spinal fusion. The CD HORIZON™ Anterior Spinal System implant components are fabricated from ASTM F138 (or its ISO equivalent) stainless steel and may be sold sterile or non-sterile. Stainless steel implants are not to be used with titanium alloy implant components in a spinal construct. IV. The CD HORIZON™ Anterior Spinal System is designed to aid in the surgical correction and stabilization of the spine. The system is intended to assist stabilization until a solid spinal fusion develops. The specific indications for the CD HORIZON™ Anterior Spinal System are the following: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). 2. Pseudoarthrosis 3. Stenosis 4. Spondylolisthesis 5. Spinal deformities: scoliosis, kyphosis, lordosis 6. Fracture 7. Unsuccessful previous attempts at spinal fusion 8. Tumor resection All components of the CD HORIZON™ Anterior Spinal System are intended to be fixed/attached to the anterolateral spine by screws/staples in the thoracic and/or lumbar areas only. V. Mechanical test data were supplied in support of the CD HORIZON™ Anterior Spinal System 510(k) notification. The CD HORIZON™ Anterior Spinal System was declared to be substantially equivalent to several commercially available devices.