Zavation Medical Products, LLC

GUDID 00842166187931

SIBI CAGE

ZAVATION LLC

Sacroiliac joint transarticular fixation/arthrodesis implantation kit

• Primary Device ID: 00842166187931
• NIH Device Record Key: 8ad0c7fc-0d33-4193-bc8a-fa9b101a4bda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zavation Medical Products, LLC
• Version Model Number: 540-742710
• Company DUNS: 069472800
• Company Name: ZAVATION LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
• 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
• 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	00842166187931 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00842166187931]

Moist Heat or Steam Sterilization

[00842166187931]

Moist Heat or Steam Sterilization

[00842166187931]

Moist Heat or Steam Sterilization

[00842166187931]

Moist Heat or Steam Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

[00842166187931]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-10
• Device Publish Date: 2020-11-02

On-Brand Devices [Zavation Medical Products, LLC]

• 00842166195301: SIBI Instrument Tray
• 00842166187023: INSERTER
• 00842166187931: SIBI CAGE
• 00842166188747: BLUNT TIP DILATOR 2
• 00842166189331: Dilator 1
• 00842166189928: TAMP
• 00842166191853: BOX CHISEL
• 00842166192379: SMALL MALLET
• 00842166186309: Inserter
• 00842166186293: Mallet
• 00842166186194: DRILL
• 00842166186187: RASP
• 00842166186170: BOX CHISEL
• 00842166186163: TAMP
• 00842166186156: DILATOR 2
• 00842166186149: DILATOR 1
• 00842166186132: STEINMANN PIN
• 00842166197107: Set Screw Inserter
• 00842166197091: Drill Guide
• 00842166197084: Set Screw Torque Shaft
• 00842166197077: 2.5mm Screw Driver-Posterior Cervical
• 00842166197060: 2.5mm Screw Driver-Posterior Cervical
• 00842166197053: 2.5mm Screw Driver-Posterior Cervical
• 00842166197046: Anti-Torque/Posterior Cervical
• 00842166197039: Set Screw Inserter
• 00842166197022: 3.5MM Drill-Posterior Cervical
• 00842166197015: 3.0MM Drill-Posterior Cervical
• 00842166197008: 2.5MM Drill-Posterior Cervical
• 00842166196995: 2.0MM Drill-Posterior Cervical
• 00842166196988: 14x16 Custom Lasered Sizer, 9 & 10MM
• 00842166196971: 14x16 Custom Lasered Sizer, 7 & 8MM
• 00842166196964: 14x16 Custom Lasered Sizer, 5 & 6MM
• 00842166196957: 12x14 Custom Lasered Sizer, 9 & 10MM
• 00842166196940: 12x14 Custom Lasered Sizer, 7 & 8MM
• 00842166196933: 12x14 Custom Lasered Sizer, 5 & 6MM
• 00842166196926: Rod Persuader Short
• 00842166196919: SI Screw Wrench
• 00842166196902: Custom Rod Rocker
• 00842166196896: eZspand Removal Tool
• 00842166196889: Custom Rod Rocker
• 00842166196872: 2.5mm K-Wire/Long
• 00842166196858: Torque Rod
• 00842166196841: Inserter Handle
• 00842166196834: Spike, Threaded Tip
• 00842166196827: Spike, Smooth Tip