NekSpine System, w/ Large Support

Basic Information

• Brand Name: NekSpine System, w/ Large Support
• Primary DI: 00810105030563
• Version / Model: 1-1011-005
• Company Name: COMPOSITE MANUFACTURING, INC.
• Labeler DUNS: 947090650
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-16
• Public Version: 1
• Public Version Date: 2023-01-24
• Public Version Status: New
• Public Device Record Key: b1505b80-895b-4ff1-8c13-06f5c28d8651

Device Description

The NekSpine is intended for relief of back and neck pain, when looking down for extended periods of time, by providing a force that counteracts the effects of gravity on the head. The device is reusable and intended for short-term use.

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IPT	Orthosis, Thoracic	Physical Medicine	890.3490	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41042	Thoracic spine orthosis	A prefabricated (non-customized) orthopaedic corset designed to encompasses the thoracic spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine through compression of the abdomen. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810105030563	GS1

Customer Contacts

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