Anatomic PEEK™ Cervical Fusion System with Nanotechnology 6208741

GUDID 00814216026453

Anatomic PEEK Trial, 7 x 14 x 11 x 10°

NANOVIS SPINE, LLC

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 00814216026453
• NIH Device Record Key: 32f9f9b6-e3c2-4f03-9894-9925dd393ac9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anatomic PEEK™ Cervical Fusion System with Nanotechnology
• Version Model Number: 6208741
• Catalog Number: 6208741
• Company DUNS: 079898044
• Company Name: NANOVIS SPINE, 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: 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: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com

Device Dimensions

• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Length: 7 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814216026453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230936

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

[00814216026453]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-03
• Device Publish Date: 2023-09-25

On-Brand Devices [Anatomic PEEK™ Cervical Fusion System with Nanotechnology]

• 00814216027887: ANATOMIC PEEK w/ Nano 14 x 11 x 5 x 10°
• 00814216028235: ANATOMIC PEEK w/ Nano 18 x 16 x 10 x 4.6°
• 00814216028228: ANATOMIC PEEK w/ Nano 18 x 16 x 9 x 4.6°
• 00814216028211: ANATOMIC PEEK w/ Nano 18 x 16 x 8 x 4.6°
• 00814216028204: ANATOMIC PEEK w/ Nano 18 x 16 x 7 x 4.6°
• 00814216028198: ANATOMIC PEEK w/ Nano 18 x 16 x 6 x 4.6°
• 00814216028181: ANATOMIC PEEK w/ Nano 18 x 16 x 5 x 4.6°
• 00814216028174: ANATOMIC PEEK w/ Nano 16 x 14 x 10 x 4.6°
• 00814216028167: ANATOMIC PEEK w/ Nano 16 x 14 x 9 x 4.6°
• 00814216028150: ANATOMIC PEEK w/ Nano 16 x 14 x 8 x 4.6°
• 00814216028143: ANATOMIC PEEK w/ Nano 16 x 14 x 7 x 4.6°
• 00814216028136: ANATOMIC PEEK w/ Nano 16 x 14 x 6 x 4.6°
• 00814216028129: ANATOMIC PEEK w/ Nano 16 x 14 x 5 x 4.6°
• 00814216028112: ANATOMIC PEEK w/ Nano 14x11x10x4.6°
• 00814216028105: ANATOMIC PEEK w/ Nano 14x11x9x4.6°
• 00814216028099: ANATOMIC PEEK w/ Nano 14x11x8x4.6°
• 00814216028082: ANATOMIC PEEK w/ Nano 14x11x7x4.6°
• 00814216028075: ANATOMIC PEEK w/ Nano 14x11x6x4.6°
• 00814216028068: ANATOMIC PEEK w/ Nano 14x11x5x4.6°
• 00814216028051: ANATOMIC PEEK w/ Nano 18 x 16 x 10 x 10°
• 00814216028044: ANATOMIC PEEK w/ Nano 18 x 16 x 9 x 10°
• 00814216028037: ANATOMIC PEEK w/ Nano 18 x 16 x 8 x 10°
• 00814216028020: ANATOMIC PEEK w/ Nano 18 x 16 x 6 x 10°
• 00814216028013: ANATOMIC PEEK w/ Nano 18 x 16 x 6 x 10°
• 00814216028006: ANATOMIC PEEK w/ Nano 18 x 16 x 5 x 10°
• 00814216027993: ANATOMIC PEEK w/ Nano 16 x 14 x 10 x 10°
• 00814216027986: ANATOMIC PEEK w/ Nano 16 x 14 x 9 x 10°
• 00814216027979: ANATOMIC PEEK w/ Nano 16 x 14 x 8 x 10°
• 00814216027962: ANATOMIC PEEK w/ Nano 16 x 14 x 7 x 10°
• 00814216027955: ANATOMIC PEEK w/ Nano 16 x 14 x 6 x 10°
• 00814216027948: ANATOMIC PEEK w/ Nano 16 x 14 x 5 x 10°
• 00814216027931: ANATOMIC PEEK w/ Nano 14 x 11 x 10 x 10°
• 00814216027924: ANATOMIC PEEK w/ Nano 14 x 11 x 9 x 10°
• 00814216027917: ANATOMIC PEEK w/ Nano 14 x 11 x 8 x 10°
• 00814216027900: ANATOMIC PEEK w/ Nano 14 x 11 x 7 x 10°
• 00814216027894: ANATOMIC PEEK w/ Nano 14 x 11 x 6 x 10°
• 00814216026620: Anatomic PEEK Trial, 10 x 18 x 16 x 10°
• 00814216026613: Anatomic PEEK Trial, 9 x 18 x 16 x 10°
• 00814216026606: Anatomic PEEK Trial, 8 x 18 x 16 x 10°
• 00814216026590: Anatomic PEEK Trial, 7 x 18 x 16 x 10°
• 00814216026583: Anatomic PEEK Trial, 6 x 18 x 16 x 10°
• 00814216026576: Anatomic PEEK Trial, 5 x 18 x 16 x 10°
• 00814216026569: Anatomic PEEK Trial, 10 x 16 x 14 x 10°
• 00814216026552: Anatomic PEEK Trial, 9 x 16 x 14 x 10°
• 00814216026545: Anatomic PEEK Trial, 8 x 16 x 14 x 10°
• 00814216026538: Anatomic PEEK Trial, 7 x 16 x 14 x 10°
• 00814216026521: Anatomic PEEK Trial, 6 x 16 x 14 x 10°
• 00814216026491: Anatomic PEEK Trial, 5 x 16 x 14 x 10°
• 00814216026484: Anatomic PEEK Trial, 10 x 14 x 11 x 10°
• 00814216026477: Anatomic PEEK Trial, 9 x 14 x 11 x 10°