M6-C

Basic Information

• Brand Name: M6-C
• Primary DI: 00812388031312
• Version / Model: FG 0169
• Catalog Number: ICC-0000-10
• Company Name: Spinal Kinetics, Inc.
• Labeler DUNS: 171513125
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-20
• Public Version: 1
• Public Version Date: 2022-04-28
• Public Version Status: New
• Public Device Record Key: 5056ddee-33cc-434e-9f2f-8c869971b74f

Device Description

M6-C Implant Case Kit – Ancillary

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: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
MJO	Prosthesis, Intervertebral Disc	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
48164	Cervical total intervertebral disc prosthesis, modular	An implantable three-component assembly of devices intended to replace a dysfunctional intervertebral disc in the cervical spine that is comprised of an upper and lower endplate for attachment to adjacent vertebrae, and a space-occupying core between the plates to allow small movements of the adjacent vertebrae. The endplates are typically made of metal, and the core ceramic or synthetic polymer materials.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812388031312	GS1

Premarket Submissions

Submission Number	Supplement Number
P170036	000