Zavation NanoPrime LABYRINTH CIF

GUDID 00197157040666

NanoPrime LABYRINTH CIF 14mmx16mm , 10deg , 07mm

Zavation LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00197157040666
• NIH Device Record Key: 5eed7458-44a7-46af-ad4f-08eec8f1da12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zavation NanoPrime LABYRINTH CIF
• Version Model Number: 952-1007
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197157040666 [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

[00197157040666]

Radiation Sterilization

[00197157040666]

Radiation Sterilization

[00197157040666]

Radiation Sterilization

[00197157040666]

Radiation Sterilization

[00197157040666]

Radiation Sterilization

[00197157040666]

Radiation Sterilization

[00197157040666]

Radiation Sterilization

[00197157040666]

Radiation Sterilization

[00197157040666]

Radiation Sterilization

[00197157040666]

Radiation Sterilization

[00197157040666]

Radiation Sterilization

[00197157040666]

Radiation Sterilization

[00197157040666]

Radiation Sterilization

[00197157040666]

Radiation Sterilization

[00197157040666]

Radiation Sterilization

[00197157040666]

Radiation Sterilization

[00197157040666]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-30
• Device Publish Date: 2024-09-20

On-Brand Devices [Zavation NanoPrime LABYRINTH CIF]

• 00197157039677: NanoPrime LABYRINTH CIF 13mmx15mm , 0deg , 12mm
• 00197157039660: NanoPrime LABYRINTH CIF 13mmx15mm , 0deg , 11mm
• 00197157039653: NanoPrime LABYRINTH CIF 13mmx15mm , 0deg , 10mm
• 00197157039646: NanoPrime LABYRINTH CIF 13mmx15mm , 0deg , 09mm
• 00197157039639: NanoPrime LABYRINTH CIF 13mmx15mm , 0deg , 08mm
• 00197157039622: NanoPrime LABYRINTH CIF 13mmx15mm , 0deg , 07mm
• 00197157039615: NanoPrime LABYRINTH CIF 13mmx15mm , 0deg , 06mm
• 00197157039608: NanoPrime LABYRINTH CIF 13mmx15mm , 0deg , 05mm
• 00197157039592: NanoPrime LABYRINTH CIF 12mmx14mm , 10deg , 12mm
• 00197157039585: NanoPrime LABYRINTH CIF 12mmx14mm , 10deg , 11mm
• 00197157039578: NanoPrime LABYRINTH CIF 12mmx14mm , 10deg , 10mm
• 00197157039561: NanoPrime LABYRINTH CIF 12mmx14mm , 10deg , 09mm
• 00197157039554: NanoPrime LABYRINTH CIF 12mmx14mm , 10deg , 08mm
• 00197157039547: NanoPrime LABYRINTH CIF 12mmx14mm , 10deg , 07mm
• 00197157039530: NanoPrime LABYRINTH CIF 12mmx14mm , 10deg , 06mm
• 00197157039523: NanoPrime LABYRINTH CIF 12mmx14mm , 10deg , 05mm
• 00197157039516: NanoPrime LABYRINTH CIF 12mmx14mm , 9deg , 12mm
• 00197157039509: NanoPrime LABYRINTH CIF 12mmx14mm , 9deg , 11mm
• 00197157039493: NanoPrime LABYRINTH CIF 12mmx14mm , 9deg , 10mm
• 00197157039486: NanoPrime LABYRINTH CIF 12mmx14mm , 9deg , 09mm
• 00197157039479: NanoPrime LABYRINTH CIF 12mmx14mm , 9deg , 08mm
• 00197157039462: NanoPrime LABYRINTH CIF 12mmx14mm , 9deg , 07mm
• 00197157039455: NanoPrime LABYRINTH CIF 12mmx14mm , 9deg , 06mm
• 00197157039448: NanoPrime LABYRINTH CIF 12mmx14mm , 9deg , 05mm
• 00197157039431: NanoPrime LABYRINTH CIF 12mmx14mm , 8deg , 12mm
• 00197157039424: NanoPrime LABYRINTH CIF 12mmx14mm , 8deg , 11mm
• 00197157039417: NanoPrime LABYRINTH CIF 12mmx14mm , 8deg , 10mm
• 00197157039400: NanoPrime LABYRINTH CIF 12mmx14mm , 8deg , 09mm
• 00197157039394: NanoPrime LABYRINTH CIF 12mmx14mm , 8deg , 08mm
• 00197157039387: NanoPrime LABYRINTH CIF 12mmx14mm , 8deg , 07mm
• 00197157039370: NanoPrime LABYRINTH CIF 12mmx14mm , 8deg , 06mm
• 00197157039363: NanoPrime LABYRINTH CIF 12mmx14mm , 8deg , 05mm
• 00197157039356: NanoPrime LABYRINTH CIF 12mmx14mm , 7deg , 12mm
• 00197157039349: NanoPrime LABYRINTH CIF 12mmx14mm , 7deg , 11mm
• 00197157039332: NanoPrime LABYRINTH CIF 12mmx14mm , 7deg , 10mm
• 00197157039325: NanoPrime LABYRINTH CIF 12mmx14mm , 7deg , 09mm
• 00197157039318: NanoPrime LABYRINTH CIF 12mmx14mm , 7deg , 08mm
• 00197157039301: NanoPrime LABYRINTH CIF 12mmx14mm , 7deg , 07mm
• 00197157039295: NanoPrime LABYRINTH CIF 12mmx14mm , 7deg , 06mm
• 00197157039288: NanoPrime LABYRINTH CIF 12mmx14mm , 7deg , 05mm
• 00197157039271: NanoPrime LABYRINTH CIF 12mmx14mm , 6deg , 12mm
• 00197157039264: NanoPrime LABYRINTH CIF 12mmx14mm , 6deg , 11mm
• 00197157039257: NanoPrime LABYRINTH CIF 12mmx14mm , 6deg , 10mm
• 00197157039240: NanoPrime LABYRINTH CIF 12mmx14mm , 6deg , 09mm
• 00197157039233: NanoPrime LABYRINTH CIF 12mmx14mm , 6deg , 08mm
• 00197157039226: NanoPrime LABYRINTH CIF 12mmx14mm , 6deg , 07mm
• 00197157039219: NanoPrime LABYRINTH CIF 12mmx14mm , 6deg , 06mm
• 00197157039202: NanoPrime LABYRINTH CIF 12mmx14mm , 6deg , 05mm
• 00197157039196: NanoPrime LABYRINTH CIF 12mmx14mm , 5deg , 12mm
• 00197157039189: NanoPrime LABYRINTH CIF 12mmx14mm , 5deg , 11mm