Zavation

GUDID 00842166178724

dilator #1 peek

ZAVATION LLC

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage

• Primary Device ID: 00842166178724
• NIH Device Record Key: 00bedc2f-3811-4079-8eed-7ccfeb526e84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zavation
• Version Model Number: 80-1049
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
• 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	00842166178724 [Primary]

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00842166178724]

Moist Heat or Steam Sterilization

[00842166178724]

Moist Heat or Steam Sterilization

[00842166178724]

Moist Heat or Steam Sterilization

[00842166178724]

Moist Heat or Steam Sterilization

[00842166178724]

Moist Heat or Steam Sterilization

[00842166178724]

Moist Heat or Steam Sterilization

[00842166178724]

Moist Heat or Steam Sterilization

[00842166178724]

Moist Heat or Steam Sterilization

[00842166178724]

Moist Heat or Steam Sterilization

[00842166178724]

Moist Heat or Steam Sterilization

[00842166178724]

Moist Heat or Steam Sterilization

[00842166178724]

Moist Heat or Steam Sterilization

[00842166178724]

Moist Heat or Steam Sterilization

[00842166178724]

Moist Heat or Steam Sterilization

[00842166178724]

Moist Heat or Steam Sterilization

[00842166178724]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-08
• Device Publish Date: 2021-03-31

On-Brand Devices [Zavation]

• 00084216611481: TLIF 30, 6deg -15
• 00842166195134: Anterior IBF Tray
• 00842166195127: Cervical Cage Tray
• 00842166195110: Z-Link Cervical Tray
• 00842166195103: Normandy Set Screw Caddy
• 00842166195097: SI Screw Tray
• 00842166195080: 1-2 Level Cervical Plate Tray
• 00842166195073: Z-Direct Instrument Tray
• 00842166195066: Normandy VBR System Tray
• 00842166195059: EZ Plate Cervical Tray
• 00842166195042: Z-Span Lateral System Tray
• 00842166195035: Z-Span Anterior System Tray
• 00842166195028: Z-Link Lumbar Tray
• 00842166195011: MIS Instrument Tray
• 00842166195004: Cervical Plate Tray
• 00842166182684: LEIF Sizer 9 x 27 x 5 deg - 13
• 00842166182677: LEIF Sizer 9 x 27 x 5 deg - 12
• 00842166182660: LEIF Sizer 9 x 27 x 5 deg - 11
• 00842166182653: LEIF Sizer 9 x 27 x 5 deg - 10
• 00842166182646: LEIF Sizer 9 x 27 x 5 deg - 09
• 00842166182639: LEIF Sizer 9 x 27 x 5 deg - 08
• 00842166182622: LEIF Sizer 9 x 23 x 5 deg - 13
• 00842166182615: LEIF Sizer 9 x 23 x 5 deg - 12
• 00842166182608: LEIF Sizer 9 x 23 x 5 deg - 11
• 00842166182592: LEIF Sizer 9 x 23 x 5 deg - 10
• 00842166182585: LEIF Sizer 9 x 23 x 5 deg - 09
• 00842166182578: LEIF Sizer 9 x 23 x 5 deg - 08
• 00842166182325: Custom Paddle
• 00842166182318: Custom Paddle
• 00842166182301: Custom Paddle
• 00842166182295: T-Handle, Ratcheting
• 00842166182004: PEDICLE FINDER, DUCKBILL, CURVED, ZAVATION
• 00842166181991: PEDICLE FINDER, ZAVATION DUCKBILL, STRAIGHT
• 00842166181984: Polyaxial Screwdriver, 2.5mm straight hex - AO Handle
• 00842166181977: K-Wire, Blunt, Smooth
• 00842166181960: Shim
• 00842166181953: Calipers - MIS
• 00842166181946: Custom Implant Holder
• 00842166181939: TORQ LMT, SM T-HDL, CSTM HEX
• 00842166181922: T-HDL, HEX DRIVER, ZAVATION
• 00842166181915: Removal Tool
• 00842166181793: Graft Pusher
• 00842166181786: Graft Funnel
• 00842166181779: Base Rotative
• 00842166181762: Table Clamp w/o Base
• 00842166181755: 21mm Dilator
• 00842166181748: 19mm Dilator
• 00842166181731: 17mm Dilator
• 00842166181724: 15mm Dilator
• 00842166181717: 13mm Dilator