Ayers Rock Cervical interbody fusion system

Basic Information

• Brand Name: Ayers Rock Cervical interbody fusion system
• Primary DI: 03663422604750
• Version / Model: 1
• Catalog Number: 336DC8S1
• Company Name: SPINEWAY
• Labeler DUNS: 281075270
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-17
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 7e37c62b-456a-41d3-be28-83d5d9dc91d8

Device Description

Sizer 8S, cervical

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: 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: Yes
• 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
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	888.3080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44054	Orthopaedic surgical procedure kit, non-medicated, reusable	A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03663422604750	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K162694	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			S
Height	8	Millimeter