Zavation

Basic Information

• Brand Name: Zavation
• Primary DI: 00842166127326
• Version / Model: VCF-1015-2-XXC
• Company Name: ZAVATION LLC
• Labeler DUNS: 069472800
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-07
• Public Version: 1
• Public Version Date: 2018-12-10
• Public Version Status: New
• Public Device Record Key: 34a81d0b-5832-4742-a617-66038d8adf23

Device Description

ZVplasty System Assembly

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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	878.4800	1
HRX	Arthroscope	Orthopedic	888.1100	2
NDN	Cement, Bone, Vertebroplasty	Orthopedic	888.3027	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47129	Balloon kyphoplasty kit	A collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842166127326	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K141419	000