Zavation NanoPrime ALIF Cage

GUDID 00197157026257

NANOPrime ALIF Cage 35 X 13MM X 20°

Zavation LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00197157026257
• NIH Device Record Key: bb6313aa-3873-4ef6-910d-a83fe629c194
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zavation NanoPrime ALIF Cage
• Version Model Number: 970-2035-13
• 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: 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: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197157026257 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233509

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

[00197157026257]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-01
• Device Publish Date: 2024-09-23

On-Brand Devices [Zavation NanoPrime ALIF Cage]

• 00197157026592: NANOPrime ALIF Cage 40 X 25MM X 30°
• 00197157026585: NANOPrime ALIF Cage 40 X 23MM X 30°
• 00197157026578: NANOPrime ALIF Cage 40 X 21MM X 30°
• 00197157026561: NANOPrime ALIF Cage 35 X 25MM X 30°
• 00197157026554: NANOPrime ALIF Cage 35 X 23MM X 30°
• 00197157026547: NANOPrime ALIF Cage 35 X 21MM X 30°
• 00197157026530: NANOPrime ALIF Cage 35 X 19MM X 30°
• 00197157026523: NANOPrime ALIF Cage 35 X 17MM X 30°
• 00197157026516: NANOPrime ALIF Cage 30 X 25MM X 30°
• 00197157026509: NANOPrime ALIF Cage 30 X 23MM X 30°
• 00197157026493: NANOPrime ALIF Cage 30 X 21MM X 30°
• 00197157026486: NANOPrime ALIF Cage 30 X 19MM X 30°
• 00197157026479: NANOPrime ALIF Cage 30 X 17MM X 30°
• 00197157026462: NANOPrime ALIF Cage 30 X 15MM X 30°
• 00197157026455: NANOPrime ALIF Cage 40 X 21MM X 25°
• 00197157026448: NANOPrime ALIF Cage 40 X 19MM X 25°
• 00197157026431: NANOPrime ALIF Cage 40 X 17MM X 25°
• 00197157026424: NANOPrime ALIF Cage 35 X 21MM X 25°
• 00197157026417: NANOPrime ALIF Cage 35 X 19MM X 25°
• 00197157026400: NANOPrime ALIF Cage 35 X 17MM X 25°
• 00197157026394: NANOPrime ALIF Cage 35 X 15MM X 25°
• 00197157026387: NANOPrime ALIF Cage 30 X 21MM X 25°
• 00197157026370: NANOPrime ALIF Cage 30 X 19MM X 25°
• 00197157026363: NANOPrime ALIF Cage 30 X 17MM X 25°
• 00197157026356: NANOPrime ALIF Cage 30 X 15MM X 25°
• 00197157026349: NANOPrime ALIF Cage 40 X 21MM X 20°
• 00197157026332: NANOPrime ALIF Cage 40 X 19MM X 20°
• 00197157026325: NANOPrime ALIF Cage 40 X 17MM X 20°
• 00197157026318: NANOPrime ALIF Cage 40 X 15MM X 20°
• 00197157026301: NANOPrime ALIF Cage 35 X 21MM X 20°
• 00197157026295: NANOPrime ALIF Cage 35 X 19MM X 20°
• 00197157026288: NANOPrime ALIF Cage 35 X 17MM X 20°
• 00197157026271: NANOPrime ALIF Cage 35 X 15MM X 20°
• 00197157026264: NANOPrime ALIF Cage 35 X 14MM X 20°
• 00197157026257: NANOPrime ALIF Cage 35 X 13MM X 20°
• 00197157026240: NANOPrime ALIF Cage 30 X 19MM X 20°
• 00197157026233: NANOPrime ALIF Cage 30 X 17MM X 20°
• 00197157026226: NANOPrime ALIF Cage 30 X 15MM X 20°
• 00197157026219: NANOPrime ALIF Cage 30 X 14MM X 20°
• 00197157026202: NANOPrime ALIF Cage 30 X 13MM X 20°
• 00197157026196: NANOPrime ALIF Cage 40 X 21MM X 15°
• 00197157026189: NANOPrime ALIF Cage 40 X 19MM X 15°
• 00197157026172: NANOPrime ALIF Cage 40 X 17MM X 15°
• 00197157026165: NANOPrime ALIF Cage 40 X 15MM X 15°
• 00197157026158: NANOPrime ALIF Cage 40 X 14MM X 15°
• 00197157026141: NANOPrime ALIF Cage 40 X 13MM X 15°
• 00197157026134: NANOPrime ALIF Cage 40 X 12MM X 15°
• 00197157026127: NANOPrime ALIF Cage 40 X 11MM X 15°
• 00197157026110: NANOPrime ALIF Cage 35 X 21MM X 15°
• 00197157026103: NANOPrime ALIF Cage 35 X 19MM X 15°