DIANA

Basic Information

• Brand Name: DIANA
• Primary DI: 04047844008423
• Version / Model: IF-Screw
• Catalog Number: SJ1918
• Company Name: SIGNUS Medizintechnik GmbH
• Labeler DUNS: 344203948
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 5
• Public Version Date: 2019-10-11
• Public Version Status: Update
• Public Device Record Key: 0d06be1a-203a-4a3c-9b9f-1f872d5f096a

Device Description

The DIANA Fusion Cage is comprised of a variety of implant sizes to accomodate various patient anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).

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: Yes
• 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
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	888.3080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58733	Sacroiliac joint intra-articular arthrodesis implant	An implantable device designed to achieve and maintain the distraction of degenerated articular surfaces of the sacroiliac joint to assist in intra- and extra-articular bone grafting and fusion (arthrodesis), typically performed to alleviate pain from the sacroiliac joints in skeletally mature patients. The device is a tapered tube made of titanium alloy which has radial fenestrations to encourage bony in-growth. It is surgically implanted under fluoroscopic guidance using an assortment of dedicated tools. It is available in several sizes and intended for permanent implantation.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04047844008423	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K091122	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			19/18x30mm

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 35 Degrees Celsius