DISCOVERY TiNano ACIF

Basic Information

• Brand Name: DISCOVERY TiNano ACIF
• Primary DI: B521105010507
• Version / Model: 105010507
• Catalog Number: 105010507
• Company Name: AURORA SPINE, INC.
• Labeler DUNS: 079119091
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-02
• Public Version: 5
• Public Version Date: 2019-02-04
• Public Version Status: Update
• Public Device Record Key: c7c624bf-b035-4b3a-bfeb-24a29a91b486
• Distribution End Date: 2019-02-01

Device Description

DISCOVERY TiNano ACIF 14mm X 16mm X 5 X 7

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

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
60841	Cardiopulmonary resuscitation feedback device, manual	A portable, manually-operated device intended to be applied to the chest of a patient experiencing cardiac arrest to assist a person trained in cardiopulmonary resuscitation (CPR) to deliver effective manual chest compressions. It typically consists of a chest plate with a large depressible button and is intended to translate an applied downward force into a well-positioned chest compression whilst indicating (e.g., with a click) when optimum force has been applied/removed; it may also assist the timing of chest compressions. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B521105010507	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K111484	000

Device Sizes

Type	Value	Unit	Text
Height	7	Millimeter
Angle	5	degree
Width	16	Millimeter
Length	14	Millimeter