Zavation

Basic Information

• Brand Name: Zavation
• Primary DI: 00842166195363
• Version / Model: 259-9001-C8
• Company Name: ZAVATION LLC
• Labeler DUNS: 069472800
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-15
• Public Version: 1
• Public Version Date: 2022-02-23
• Public Version Status: New
• Public Device Record Key: 1e1935df-2e52-42af-9477-112b5746d21a

Device Description

22mm Rectangular Plates Caddy

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: No
• 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
PLR	Spinal Vertebral Body Replacement Device - Cervical	Orthopedic	888.3060	2
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	888.3060	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61198	Posterior lumbar spine prosthesis	A sterile implantable device designed to replace anatomical structures removed from the posterior aspect of lumbar vertebrae (i.e., the lamina, facet joint, and bony elements) during spinal decompression surgery to provide stability to, and enable normal range of motion of, the lumbar spine. It consists of a two-plate unit positioned in the posterior midline, which connects horizontal rods that are attached laterally to adjacent vertebrae with pedicle screws; the plates include interlocking trunnions for rotational/angular motion. The device may be a single unit or modular assembled during implantation. Dedicated tools for implantation are included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842166195363	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K180673	000