Savant Lumbar Interbody Fusion System

GUDID B648C30422100800

PEEK PLIF Spacer, 22 x 10 x 8mm, 0 deg

CURITEVA, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: B648C30422100800
• NIH Device Record Key: 9c96bd6e-ed8e-48ee-a98b-5543309eb8af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Savant Lumbar Interbody Fusion System
• Version Model Number: C304-221008-0
• 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: 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: +1 (877) 928-7483
• Email: support@curiteva.com

Device Dimensions

• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B648C30422100800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181589

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[B648C30422100800]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-08-15

On-Brand Devices [Savant Lumbar Interbody Fusion System]

• B648C40432111600: PEEK TLIF Spacer, 32 x 11 x 16mm, 0 deg
• B648C40432111500: PEEK TLIF Spacer, 32 x 11 x 15mm, 0 deg
• B648C40432111400: PEEK TLIF Spacer, 32 x 11 x 14mm, 0 deg
• B648C40432111300: PEEK TLIF Spacer, 32 x 11 x 13mm, 0 deg
• B648C40432111200: PEEK TLIF Spacer, 32 x 11 x 12mm, 0 deg
• B648C40432111100: PEEK TLIF Spacer, 32 x 11 x 11mm, 0 deg
• B648C40432111000: PEEK TLIF Spacer, 32 x 11 x 10mm, 0 deg
• B648C40432110900: PEEK TLIF Spacer, 32 x 11 x 9mm, 0 deg
• B648C40432110800: PEEK TLIF Spacer, 32 x 11 x 8mm, 0 deg
• B648C40432110700: PEEK TLIF Spacer, 32 x 11 x 7mm, 0 deg
• B648C40432110600: PEEK TLIF Spacer, 32 x 11 x 6mm, 0 deg
• B648C40432091600: PEEK TLIF Spacer, 32 x 9 x 16mm, 0 deg
• B648C40432091500: PEEK TLIF Spacer, 32 x 9 x 15mm, 0 deg
• B648C40432091400: PEEK TLIF Spacer, 32 x 9 x 14mm, 0 deg
• B648C40432091300: PEEK TLIF Spacer, 32 x 9 x 13mm, 0 deg
• B648C40432091200: PEEK TLIF Spacer, 32 x 9 x 12mm, 0 deg
• B648C40432091100: PEEK TLIF Spacer, 32 x 9 x 11mm, 0 deg
• B648C40432091000: PEEK TLIF Spacer, 32 x 9 x 10mm, 0 deg
• B648C40432090900: PEEK TLIF Spacer, 32 x 9 x 9mm, 0 deg
• B648C40432090800: PEEK TLIF Spacer, 32 x 9 x 8mm, 0 deg
• B648C40432090700: PEEK TLIF Spacer, 32 x 9 x 7mm, 0 deg
• B648C40432090600: PEEK TLIF Spacer, 32 x 9 x 6mm, 0 deg
• B648C40428111600: PEEK TLIF Spacer, 28 x 11 x 16mm, 0 deg
• B648C40428111500: PEEK TLIF Spacer, 28 x 11 x 15mm, 0 deg
• B648C40428111400: PEEK TLIF Spacer, 28 x 11 x 14mm, 0 deg
• B648C40428111300: PEEK TLIF Spacer, 28 x 11 x 13mm, 0 deg
• B648C40428111200: PEEK TLIF Spacer, 28 x 11 x 12mm, 0 deg
• B648C40428111100: PEEK TLIF Spacer, 28 x 11 x 11mm, 0 deg
• B648C40428111000: PEEK TLIF Spacer, 28 x 11 x 10mm, 0 deg
• B648C40428110900: PEEK TLIF Spacer, 28 x 11 x 9mm, 0 deg
• B648C40428110800: PEEK TLIF Spacer, 28 x 11 x 8mm, 0 deg
• B648C40428110700: PEEK TLIF Spacer, 28 x 11 x 7mm, 0 deg
• B648C40428110600: PEEK TLIF Spacer, 28 x 11 x 6mm, 0 deg
• B648C40428091600: PEEK TLIF Spacer, 28 x 9 x 16mm, 0 deg
• B648C40428091500: PEEK TLIF Spacer, 28 x 9 x 15mm, 0 deg
• B648C40428091400: PEEK TLIF Spacer, 28 x 9 x 14mm, 0 deg
• B648C40428091300: PEEK TLIF Spacer, 28 x 9 x 13mm, 0 deg
• B648C40428091200: PEEK TLIF Spacer, 28 x 9 x 12mm, 0 deg
• B648C40428091100: PEEK TLIF Spacer, 28 x 9 x 11mm, 0 deg
• B648C40428091000: PEEK TLIF Spacer, 28 x 9 x 10mm, 0 deg
• B648C40428090900: PEEK TLIF Spacer, 28 x 9 x 9mm, 0 deg
• B648C40428090800: PEEK TLIF Spacer, 28 x 9 x 8mm, 0 deg
• B648C40428090700: PEEK TLIF Spacer, 28 x 9 x 7mm, 0 deg
• B648C40428090600: PEEK TLIF Spacer, 28 x 9 x 6mm, 0 deg
• B648C30430101680: PEEK PLIF Spacer, 30 x 10 x 16mm, 8 deg
• B648C30430101600: PEEK PLIF Spacer, 30 x 10 x 16mm, 0 deg
• B648C30430101580: PEEK PLIF Spacer, 30 x 10 x 15mm, 8 deg
• B648C30430101500: PEEK PLIF Spacer, 30 x 10 x 15mm, 0 deg
• B648C30430101480: PEEK PLIF Spacer, 30 x 10 x 14mm, 8 deg
• B648C30430101400: PEEK PLIF Spacer, 30 x 10 x 14mm, 0 deg