Zavation

GUDID 00842166195721

11g Vertebroplasty Kit

Zavation LLC

Balloon kyphoplasty kit

• Primary Device ID: 00842166195721
• NIH Device Record Key: 9199a18e-4324-4e5e-8505-d1f4fa91b912
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zavation
• Version Model Number: VCF-1000-11-VK
• Company DUNS: 069472800
• Company Name: Zavation LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 601-919-1119
• Email: info@zavation.com
• Phone: 601-919-1119
• Email: info@zavation.com
• Phone: 601-919-1119
• Email: info@zavation.com
• Phone: 601-919-1119
• Email: info@zavation.com
• Phone: 601-919-1119
• Email: info@zavation.com
• Phone: 601-919-1119
• Email: info@zavation.com
• Phone: 601-919-1119
• Email: info@zavation.com
• Phone: 601-919-1119
• Email: info@zavation.com
• Phone: 601-919-1119
• Email: info@zavation.com
• Phone: 601-919-1119
• Email: info@zavation.com
• Phone: 601-919-1119
• Email: info@zavation.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842166195721 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141419

FDA Product Code

• NDN: Cement, Bone, Vertebroplasty

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-04-26
• Device Publish Date: 2022-11-01

On-Brand Devices [Zavation]

• 00084216611481: TLIF 30, 6deg -15
• 00842166176768: MIS Caliper
• 00842166176607: MIS Compressor/Distractor
• 00842166176591: 25mm Dilator
• 00842166176584: 22mm Dilator
• 00842166176577: 19mm Dilator
• 00842166176560: 16mm Dilator
• 00842166176553: 13mm Dilator
• 00842166176546: 10mm Dilator
• 00842166176508: K-Wire, Blunt, Smooth
• 00842166176225: Parellel Distractor for 6.0mm
• 00842166176218: Parallel Compressor
• 00842166176119: Caliper
• 00842166176058: Large-T Torque Limiting Handle
• 00842166175167: Custom Distractor
• 00842166118324: Rod Cutter, 3.5mm
• 00842166118317: Torque Limiting Axial Handle, 25 in-lbs
• 00842166118294: Straight Handle, Spinner top
• 00842166118270: Rod Persuader, 3.5mm
• 00842166118263: Hook, Offset, Crosslink Inserter, scissor type
• 00842166118249: Rod Rocker
• 00842166118225: Hook Trial, 6.0mm
• 00842166118218: Hook Trial, 4.5mm
• 00842166118195: Torque Shaft, T-15
• 00842166118188: Set Screw Inserter, T-15
• 00842166118171: Polyaxial Screwdriver, 2.5mm straight hex - large handle
• 00842166118164: Polyaxial Screwdriver, 2.5mm straight hex - small handle
• 00842166118140: Tap 4.0mm
• 00842166118133: Tap 3.5mm
• 00842166118126: Tap 3.0mm
• 00842166118119: Screw Head Positioner
• 00842166118041: Drill Guide - 10-52mm height range
• 00842166118034: Awl - 2.0mm (0.078") diameter, 6mm tip length
• 00842166118027: Polyaxial Shaft Screw 4.0x50mm
• 00842166118010: Polyaxial Shaft Screw 4.0x48mm
• 00842166118003: Polyaxial Shaft Screw 4.0x46mm
• 00842166117990: Polyaxial Shaft Screw 4.0x44mm
• 00842166117983: Polyaxial Shaft Screw 4.0x42mm
• 00842166117976: Polyaxial Shaft Screw 4.0x40mm
• 00842166117969: Polyaxial Shaft Screw 4.0x38mm
• 00842166117952: Polyaxial Shaft Screw 4.0x36mm
• 00842166117945: Polyaxial Shaft Screw 4.0x34mm
• 00842166117938: Polyaxial Shaft Screw 4.0x32mm
• 00842166117921: Polyaxial Shaft Screw 4.0x30mm
• 00842166117914: Polyaxial Shaft Screw 4.0x28mm
• 00842166117907: Polyaxial Shaft Screw 4.0x26mm
• 00842166117891: Polyaxial Shaft Screw 4.0x24mm
• 00842166117884: Polyaxial Shaft Screw 4.0x22mm
• 00842166117877: Polyaxial Shaft Screw 4.0x20mm
• 00842166117860: 3.5mm x 50mm Polyaxial Shaft Screw