ZAVATION Lateral CL5 PEEK NanoPrime Cage

GUDID 00197157027636

Lateral CL5 PEEK NanoPrime Cage - 22mm x 55mm x 8mm, 8°

Zavation LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00197157027636
• NIH Device Record Key: 713acc5e-695d-4a2e-bbe4-9df1726e1981
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZAVATION Lateral CL5 PEEK NanoPrime Cage
• Version Model Number: NLL2255-0808
• 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
• 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	00197157027636 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231743

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[00197157027636]

Moist Heat or Steam Sterilization

[00197157027636]

Moist Heat or Steam Sterilization

[00197157027636]

Moist Heat or Steam Sterilization

[00197157027636]

Moist Heat or Steam Sterilization

[00197157027636]

Moist Heat or Steam Sterilization

[00197157027636]

Moist Heat or Steam Sterilization

[00197157027636]

Moist Heat or Steam Sterilization

[00197157027636]

Moist Heat or Steam Sterilization

[00197157027636]

Moist Heat or Steam Sterilization

[00197157027636]

Moist Heat or Steam Sterilization

[00197157027636]

Moist Heat or Steam Sterilization

[00197157027636]

Moist Heat or Steam Sterilization

[00197157027636]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-17
• Device Publish Date: 2025-07-09

On-Brand Devices [ZAVATION Lateral CL5 PEEK NanoPrime Cage]

• 00197157027414: Lateral CL5 PEEK NanoPrime Cage - 18mm x 45mm x 12mm, 8°
• 00197157027407: Lateral CL5 PEEK NanoPrime Cage - 18mm x 45mm x 10mm, 8°
• 00197157027391: Lateral CL5 PEEK NanoPrime Cage - 18mm x 45mm x 8mm, 8°
• 00197157027384: Lateral CL5 PEEK NanoPrime Cage - 22mm x 60mm x 14mm, 0°
• 00197157027377: Lateral CL5 PEEK NanoPrime Cage - 22mm x 60mm x 12mm, 0°
• 00197157027360: Lateral CL5 PEEK NanoPrime Cage - 22mm x 60mm x 10mm, 0°
• 00197157027353: Lateral CL5 PEEK NanoPrime Cage - 22mm x 60mm x 8mm, 0°
• 00197157027346: Lateral CL5 PEEK NanoPrime Cage - 22mm x 55mm x 14mm, 0°
• 00197157027339: Lateral CL5 PEEK NanoPrime Cage - 22mm x 55mm x 12mm, 0°
• 00197157027322: Lateral CL5 PEEK NanoPrime Cage - 22mm x 55mm x 10mm, 0°
• 00197157027315: Lateral CL5 PEEK NanoPrime Cage - 22mm x 55mm x 8mm, 0°
• 00197157027308: Lateral CL5 PEEK NanoPrime Cage - 22mm x 50mm x 14mm, 0°
• 00197157027292: Lateral CL5 PEEK NanoPrime Cage - 22mm x 50mm x 12mm, 0°
• 00197157027285: Lateral CL5 PEEK NanoPrime Cage - 22mm x 50mm x 10mm, 0°
• 00197157027278: Lateral CL5 PEEK NanoPrime Cage - 22mm x 50mm x 8mm, 0°
• 00197157027261: Lateral CL5 PEEK NanoPrime Cage - 22mm x 45mm x 14mm, 0°
• 00197157027254: Lateral CL5 PEEK NanoPrime Cage - 22mm x 45mm x 12mm, 0°
• 00197157027247: Lateral CL5 PEEK NanoPrime Cage - 22mm x 45mm x 10mm, 0°
• 00197157027230: Lateral CL5 PEEK NanoPrime Cage - 22mm x 45mm x 8mm, 0°
• 00197157027223: Lateral CL5 PEEK NanoPrime Cage - 18mm x 60mm x 14mm, 0°
• 00197157027216: Lateral CL5 PEEK NanoPrime Cage - 18mm x 60mm x 12mm, 0°
• 00197157027209: Lateral CL5 PEEK NanoPrime Cage - 18mm x 60mm x 10mm, 0°
• 00197157027193: Lateral CL5 PEEK NanoPrime Cage - 18mm x 55mm x 8mm, 0°
• 00197157027186: Lateral CL5 PEEK NanoPrime Cage - 18mm x 50mm x 14mm, 0°
• 00197157027179: Lateral CL5 PEEK NanoPrime Cage - 18mm x 50mm x 12mm, 0°
• 00197157027162: Lateral CL5 PEEK NanoPrime Cage - 18mm x 50mm x 10mm, 0°
• 00197157027155: Lateral CL5 PEEK NanoPrime Cage - 18mm x 50mm x 8mm, 0°
• 00197157027148: Lateral CL5 PEEK NanoPrime Cage - 18mm x 45mm x 14mm, 0°
• 00197157027131: Lateral CL5 PEEK NanoPrime Cage - 18mm x 45mm x 12mm, 0°
• 00197157027124: Lateral CL5 PEEK NanoPrime Cage - 18mm x 45mm x 10mm, 0°
• 00197157027117: Lateral CL5 PEEK NanoPrime Cage - 18mm x 45mm x 8mm, 0°
• 00197157027988: Lateral CL5 PEEK NanoPrime Cage - 18mm x 60mm x 8mm, 0°
• 00197157027971: Lateral CL5 PEEK NanoPrime Cage - 18mm x 55mm x 14mm, 0°
• 00197157027964: Lateral CL5 PEEK NanoPrime Cage - 18mm x 55mm x 12mm, 0°
• 00197157027957: Lateral CL5 PEEK NanoPrime Cage - 18mm x 55mm x 10mm, 0°
• 00197157027940: Lateral CL5 PEEK NanoPrime Cage - 22mm x 60mm x 14mm, 12°
• 00197157027933: Lateral CL5 PEEK NanoPrime Cage - 22mm x 60mm x 12mm, 12°
• 00197157027926: Lateral CL5 PEEK NanoPrime Cage - 22mm x 60mm x 10mm, 12°
• 00197157027919: Lateral CL5 PEEK NanoPrime Cage - 22mm x 55mm x 14mm, 12°
• 00197157027902: Lateral CL5 PEEK NanoPrime Cage - 22mm x 55mm x 12mm, 12°
• 00197157027896: Lateral CL5 PEEK NanoPrime Cage - 22mm x 55mm x 10mm, 12°
• 00197157027889: Lateral CL5 PEEK NanoPrime Cage - 22mm x 50mm x 14mm, 12°
• 00197157027872: Lateral CL5 PEEK NanoPrime Cage - 22mm x 50mm x 12mm, 12°
• 00197157027865: Lateral CL5 PEEK NanoPrime Cage - 22mm x 50mm x 10mm, 12°
• 00197157027858: Lateral CL5 PEEK NanoPrime Cage - 22mm x 45mm x 14mm, 12°
• 00197157027841: Lateral CL5 PEEK NanoPrime Cage - 22mm x 45mm x 12mm, 12°
• 00197157027834: Lateral CL5 PEEK NanoPrime Cage - 22mm x 45mm x 10mm, 12°
• 00197157027827: Lateral CL5 PEEK NanoPrime Cage - 18mm x 60mm x 14mm, 12°
• 00197157027810: Lateral CL5 PEEK NanoPrime Cage - 18mm x 60mm x 12mm, 12°
• 00197157027803: Lateral CL5 PEEK NanoPrime Cage - 18mm x 60mm x 10mm, 12°