ZAVATION NanoPrime LABYRINTH PLIF

GUDID 00197157068608

NanoPrime LABYRINTH PLIF 10mmx23mmx5deg -8mm

Zavation LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00197157068608
• NIH Device Record Key: 95874b07-ac29-4f06-b371-829d48aecae0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZAVATION NanoPrime LABYRINTH PLIF
• Version Model Number: 954-102305-08
• 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: 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: 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	00197157068608 [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: true

[00197157068608]

Radiation Sterilization

[00197157068608]

Radiation Sterilization

[00197157068608]

Radiation Sterilization

[00197157068608]

Radiation Sterilization

[00197157068608]

Radiation Sterilization

[00197157068608]

Radiation Sterilization

[00197157068608]

Radiation Sterilization

[00197157068608]

Radiation Sterilization

[00197157068608]

Radiation Sterilization

[00197157068608]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-16
• Device Publish Date: 2025-06-06

On-Brand Devices [ZAVATION NanoPrime LABYRINTH PLIF ]

• 00197157068578: NanoPrime LABYRINTH PLIF 10mmx23mmx0deg -14mm
• 00197157068561: NanoPrime LABYRINTH PLIF 10mmx23mmx0deg -13mm
• 00197157068554: NanoPrime LABYRINTH PLIF 10mmx23mmx0deg -12mm
• 00197157068547: NanoPrime LABYRINTH PLIF 10mmx23mmx0deg -11mm
• 00197157068530: NanoPrime LABYRINTH PLIF 10mmx23mmx0deg -10mm
• 00197157068523: NanoPrime LABYRINTH PLIF 10mmx23mmx0deg -9mm
• 00197157068516: NanoPrime LABYRINTH PLIF 10mmx23mmx0deg -8mm
• 00197157068509: NanoPrime LABYRINTH PLIF 10mmx23mmx0deg -7mm
• 00197157069582: NanoPrime LABYRINTH PLIF 10mmx32mmx12deg -16mm
• 00197157069575: NanoPrime LABYRINTH PLIF 10mmx32mmx12deg -15mm
• 00197157069568: NanoPrime LABYRINTH PLIF 10mmx32mmx12deg -14mm
• 00197157069551: NanoPrime LABYRINTH PLIF 10mmx32mmx12deg -13mm
• 00197157069544: NanoPrime LABYRINTH PLIF 10mmx32mmx12deg -12mm
• 00197157069537: NanoPrime LABYRINTH PLIF 10mmx32mmx12deg -11mm
• 00197157069520: NanoPrime LABYRINTH PLIF 10mmx32mmx12deg -10mm
• 00197157069513: NanoPrime LABYRINTH PLIF 10mmx32mmx7deg -16mm
• 00197157069506: NanoPrime LABYRINTH PLIF 10mmx32mmx7deg -15mm
• 00197157069490: NanoPrime LABYRINTH PLIF 10mmx32mmx7deg -14mm
• 00197157069483: NanoPrime LABYRINTH PLIF 10mmx32mmx7deg -13mm
• 00197157069476: NanoPrime LABYRINTH PLIF 10mmx32mmx7deg -12mm
• 00197157069469: NanoPrime LABYRINTH PLIF 10mmx32mmx7deg -11mm
• 00197157069452: NanoPrime LABYRINTH PLIF 10mmx32mmx7deg -10mm
• 00197157069445: NanoPrime LABYRINTH PLIF 10mmx32mmx7deg -9mm
• 00197157069438: NanoPrime LABYRINTH PLIF 10mmx32mmx7deg -8mm
• 00197157069421: NanoPrime LABYRINTH PLIF 10mmx32mmx5deg -16mm
• 00197157069414: NanoPrime LABYRINTH PLIF 10mmx32mmx5deg -15mm
• 00197157069407: NanoPrime LABYRINTH PLIF 10mmx32mmx5deg -14mm
• 00197157069391: NanoPrime LABYRINTH PLIF 10mmx32mmx5deg -13mm
• 00197157069384: NanoPrime LABYRINTH PLIF 10mmx32mmx5deg -12mm
• 00197157069377: NanoPrime LABYRINTH PLIF 10mmx32mmx5deg -11mm
• 00197157069360: NanoPrime LABYRINTH PLIF 10mmx32mmx5deg -10mm
• 00197157069353: NanoPrime LABYRINTH PLIF 10mmx32mmx5deg -9mm
• 00197157069346: NanoPrime LABYRINTH PLIF 10mmx32mmx5deg -8mm
• 00197157069339: NanoPrime LABYRINTH PLIF 10mmx32mmx0deg -16mm
• 00197157069322: NanoPrime LABYRINTH PLIF 10mmx32mmx0deg -15mm
• 00197157069315: NanoPrime LABYRINTH PLIF 10mmx32mmx0deg -14mm
• 00197157069308: NanoPrime LABYRINTH PLIF 10mmx32mmx0deg -13mm
• 00197157069292: NanoPrime LABYRINTH PLIF 10mmx32mmx0deg -12mm
• 00197157069285: NanoPrime LABYRINTH PLIF 10mmx32mmx0deg -11mm
• 00197157069278: NanoPrime LABYRINTH PLIF 10mmx32mmx0deg -10mm
• 00197157069261: NanoPrime LABYRINTH PLIF 10mmx32mmx0deg -9mm
• 00197157069254: NanoPrime LABYRINTH PLIF 10mmx32mmx0deg -8mm
• 00197157069247: NanoPrime LABYRINTH PLIF 10mmx32mmx0deg -7mm
• 00197157069230: NanoPrime LABYRINTH PLIF 10mmx27mmx12deg -16mm
• 00197157069223: NanoPrime LABYRINTH PLIF 10mmx27mmx12deg -15mm
• 00197157069216: NanoPrime LABYRINTH PLIF 10mmx27mmx12deg -14mm
• 00197157069209: NanoPrime LABYRINTH PLIF 10mmx27mmx12deg -13mm
• 00197157069193: NanoPrime LABYRINTH PLIF 10mmx27mmx12deg -12mm
• 00197157069186: NanoPrime LABYRINTH PLIF 10mmx27mmx12deg -11mm
• 00197157069179: NanoPrime LABYRINTH PLIF 10mmx27mmx12deg -10mm