CDH LEGACY 5.5 CANN MAS 8.5X25
CD HORIZON® Spinal System - 7578525
Device Description
A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a K-Wire, it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Length: 25.0 Millimeter
- Outer Diameter: 8.5 Millimeter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
Product Codes
Code: NKB
Device Name: Thoracolumbosacral Pedicle Screw System
Device Class: 2
Physical State: N/A
Definition: Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
Submission Type ID: 1
Review Panel: OR
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: 888.3070
Third Party Flag: N
Medical Specialty: OR
Code: MNH
Device Name: Orthosis, Spondylolisthesis Spinal Fixation
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: OR
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: 888.3070
Third Party Flag: N
Medical Specialty: OR
Code: OSH
Device Name: Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Device Class: 2
Physical State: Bone screws, rods, and hooks intended to stabilize the spine as an adjunct to fusion
Definition: Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.
Submission Type ID: 1
Review Panel: OR
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Acts as a spinal fusion system with autograft and/or allograft to stabilize the spine as an adjunct to fusion to treat adolescent idiopathic scoliosis
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: Posterior, non-cervical spinal column in adolescent patients
Regulation Number: 888.3070
Third Party Flag: N
Medical Specialty: OR
Code: KWQ
Device Name: Appliance, Fixation, Spinal Intervertebral Body
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: OR
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: 888.3060
Third Party Flag: N
Medical Specialty: OR
Code: MNI
Device Name: Orthosis, Spinal Pedicle Fixation
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: OR
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: 888.3070
Third Party Flag: N
Medical Specialty: OR
Code: KWP
Device Name: Appliance, Fixation, Spinal Interlaminal
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: OR
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: 888.3050
Third Party Flag: N
Medical Specialty: OR
Device IdentifiersDevice Id: 00885074239804
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A