Inspire Lumbar Interbody Fusion System

GUDID B648C43428091081

Porous PEEK TLIF Spacer, 28 x 9 x 10mm, 8 deg

CURITEVA, INC.

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• Primary Device ID: B648C43428091081
• NIH Device Record Key: 191f291f-7151-43b0-89d9-3c16ce770741
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inspire Lumbar Interbody Fusion System
• Version Model Number: C434-280910-8
• Company DUNS: 074575332
• Company Name: CURITEVA, INC.
• 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: true
• 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: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com

Device Dimensions

• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 28 Millimeter
• Angle: 8 degree
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 28 Millimeter
• Angle: 8 degree
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 28 Millimeter
• Angle: 8 degree
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 28 Millimeter
• Angle: 8 degree
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 28 Millimeter
• Angle: 8 degree
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 28 Millimeter
• Angle: 8 degree
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 28 Millimeter
• Angle: 8 degree
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 28 Millimeter
• Angle: 8 degree
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 28 Millimeter
• Angle: 8 degree
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 28 Millimeter
• Angle: 8 degree
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 28 Millimeter
• Angle: 8 degree
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 28 Millimeter
• Angle: 8 degree
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 28 Millimeter
• Angle: 8 degree
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 28 Millimeter
• Angle: 8 degree
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 28 Millimeter
• Angle: 8 degree
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 28 Millimeter
• Angle: 8 degree
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 28 Millimeter
• Angle: 8 degree

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B648C43428091081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233744

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-04
• Device Publish Date: 2024-06-26

On-Brand Devices [Inspire Lumbar Interbody Fusion System]

• B648C43428091381: Porous PEEK TLIF Spacer, 28 x 9 x 13mm, 8 deg
• B648C43428091281: Porous PEEK TLIF Spacer, 28 x 9 x 12mm, 8 deg
• B648C43428091181: Porous PEEK TLIF Spacer, 28 x 9 x 11mm, 8 deg
• B648C43428091081: Porous PEEK TLIF Spacer, 28 x 9 x 10mm, 8 deg
• B648C43428090981: Porous PEEK TLIF Spacer, 28 x 9 x 9mm, 8 deg
• B648C43428090881: Porous PEEK TLIF Spacer, 28 x 9 x 8mm, 8 deg
• B648C43428090781: Porous PEEK TLIF Spacer, 28 x 9 x 7mm, 8 deg