BRYAN® Cervical Disc System

Basic Information

• Brand Name: BRYAN® Cervical Disc System
• Primary DI: 00613994365316
• Version / Model: 6478414
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Labeler DUNS: 830350380
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f99c1091-a7f8-4498-b546-5353a2e7ea8f

Device Description

DISC 6478414 MILLING 14MM

Device Characteristics

• Single Use: Yes
• 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: 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: Yes
• 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
61093	Cervical orthopaedic reamer	A sterile orthopaedic surgical instrument designed to cut and resurface with precision, the opposing endplates of adjacent cervical vertebrae, for the acceptance of an intervertebral disc prosthesis. It is intended to mimic the shape of an intervertebral disc, and is attached to a shaft for connection to a manual or powered handle. It is typically made of a high-grade stainless steel alloy and is available in various sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00613994365316	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P060023	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	14.0	Millimeter