CD HORIZON® Spinal System

Basic Information

• Brand Name: CD HORIZON® Spinal System
• Primary DI: 00643169414716
• Version / Model: 25100105
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Labeler DUNS: 830350380
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-02
• Public Version: 4
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: 08d1d444-f74e-4626-8942-066a6be0c41c

Device Description

TAP 25100105 NGSP TAP 10.5MM CANNULATED

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	Orthopedic	888.3050	2
MNH	Orthosis, spondylolisthesis spinal fixation	Orthopedic	888.3070	2
KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY	Orthopedic	888.3060	2
OSH	Pedicle screw spinal system, adolescent idiopathic scoliosis	Orthopedic	888.3070	2
HWE	INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT	General, Plastic Surgery	878.4820	1
MNI	ORTHOSIS, SPINAL PEDICLE FIXATION	Orthopedic	888.3070	2
OLO	Orthopedic stereotaxic instrument	Neurology	882.4560	2
NKB	Thoracolumbosacral pedicle screw system	Orthopedic	888.3070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17507	Bone tap, reusable	A surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643169414716	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K153442	000