Acumen Thoracolumbar Plate System

GUDID B648C11540428S0

Acumen, THORACOLUMBAR PLATE, FOUR HOLE, SACRAL, FLAT, 28mm

CURITEVA, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: B648C11540428S0
• NIH Device Record Key: 5c6b915d-5c6a-489b-bcdf-94f21b509c4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acumen Thoracolumbar Plate System
• Version Model Number: C1154-0428-S
• 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
• 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

• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B648C11540428S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233360

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[B648C11540428S0]

Moist Heat or Steam Sterilization

[B648C11540428S0]

Moist Heat or Steam Sterilization

[B648C11540428S0]

Moist Heat or Steam Sterilization

[B648C11540428S0]

Moist Heat or Steam Sterilization

[B648C11540428S0]

Moist Heat or Steam Sterilization

[B648C11540428S0]

Moist Heat or Steam Sterilization

[B648C11540428S0]

Moist Heat or Steam Sterilization

[B648C11540428S0]

Moist Heat or Steam Sterilization

[B648C11540428S0]

Moist Heat or Steam Sterilization

[B648C11540428S0]

Moist Heat or Steam Sterilization

[B648C11540428S0]

Moist Heat or Steam Sterilization

[B648C11540428S0]

Moist Heat or Steam Sterilization

[B648C11540428S0]

Moist Heat or Steam Sterilization

[B648C11540428S0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-08
• Device Publish Date: 2024-10-31

On-Brand Devices [Acumen Thoracolumbar Plate System]

• B648C11557000: SELF-RETAINING LUMBAR SCREW DRIVER
• B648C11554100: Self-Centering Awl, 3.0 X 15mm
• B648C11551300: PLATE FORCEPS
• B648C11545540VST0: Acumen, 5.5 X 40mm, SELF-TAPPING, VARIABLE THORACOLUMBAR SCREW
• B648C11545540VSD0: Acumen, 5.5 X 40mm, SELF-DRILLING, VARIABLE THORACOLUMBAR SCREW
• B648C11545540FST0: Acumen, 5.5 X 40mm, SELF-TAPPING, FIXED THORACOLUMBAR SCREW
• B648C11545540FSD0: Acumen, 5.5 X 40mm, SELF-DRILLING, FIXED THORACOLUMBAR SCREW
• B648C11545535VST0: Acumen, 5.5 X 35mm, SELF-TAPPING, VARIABLE THORACOLUMBAR SCREW
• B648C11545535VSD0: Acumen, 5.5 X 35mm, SELF-DRILLING, VARIABLE THORACOLUMBAR SCREW
• B648C11545535FST0: Acumen, 5.5 X 35mm, SELF-TAPPING, FIXED THORACOLUMBAR SCREW
• B648C11545535FSD0: Acumen, 5.5 X 35mm, SELF-DRILLING, FIXED THORACOLUMBAR SCREW
• B648C11545530VST0: Acumen, 5.5 X 30mm, SELF-TAPPING, VARIABLE THORACOLUMBAR SCREW
• B648C11545530VSD0: Acumen, 5.5 X 30mm, SELF-DRILLING, VARIABLE THORACOLUMBAR SCREW
• B648C11545530FST0: Acumen, 5.5 X 30mm, SELF-TAPPING, FIXED THORACOLUMBAR SCREW
• B648C11545530FSD0: Acumen, 5.5 X 30mm, SELF-DRILLING, FIXED THORACOLUMBAR SCREW
• B648C11545525VST0: Acumen, 5.5 X 25mm, SELF-TAPPING, VARIABLE THORACOLUMBAR SCREW
• B648C11545525VSD0: Acumen, 5.5 X 25mm, SELF-DRILLING, VARIABLE THORACOLUMBAR SCREW
• B648C11545525FST0: Acumen, 5.5 X 25mm, SELF-TAPPING, FIXED THORACOLUMBAR SCREW
• B648C11545525FSD0: Acumen, 5.5 X 25mm, SELF-DRILLING, FIXED THORACOLUMBAR SCREW
• B648C11545520VST0: Acumen, 5.5 X 20mm, SELF-TAPPING, VARIABLE THORACOLUMBAR SCREW
• B648C11545520VSD0: Acumen, 5.5 X 20mm, SELF-DRILLING, VARIABLE THORACOLUMBAR SCREW
• B648C11545520FST0: Acumen, 5.5 X 20mm, SELF-TAPPING, FIXED THORACOLUMBAR SCREW
• B648C11545520FSD0: Acumen, 5.5 X 20mm, SELF-DRILLING, FIXED THORACOLUMBAR SCREW
• B648C11545040VST0: Acumen, 5.0 X 40mm, SELF-TAPPING, VARIABLE THORACOLUMBAR SCREW
• B648C11545040VSD0: Acumen, 5.0 X 40mm, SELF-DRILLING, VARIABLE THORACOLUMBAR SCREW
• B648C11545040FST0: Acumen, 5.0 X 40mm, SELF-TAPPING, FIXED THORACOLUMBAR SCREW
• B648C11545040FSD0: Acumen, 5.0 X 40mm, SELF-DRILLING, FIXED THORACOLUMBAR SCREW
• B648C11545035VST0: Acumen, 5.0 X 35mm, SELF-TAPPING, VARIABLE THORACOLUMBAR SCREW
• B648C11545035VSD0: Acumen, 5.0 X 35mm, SELF-DRILLING, VARIABLE THORACOLUMBAR SCREW
• B648C11545035FST0: Acumen, 5.0 X 35mm, SELF-TAPPING, FIXED THORACOLUMBAR SCREW
• B648C11545035FSD0: Acumen, 5.0 X 35mm, SELF-DRILLING, FIXED THORACOLUMBAR SCREW
• B648C11545030VST0: Acumen, 5.0 X 30mm, SELF-TAPPING, VARIABLE THORACOLUMBAR SCREW
• B648C11545030VSD0: Acumen, 5.0 X 30mm, SELF-DRILLING, VARIABLE THORACOLUMBAR SCREW
• B648C11545030FST0: Acumen, 5.0 X 30mm, SELF-TAPPING, FIXED THORACOLUMBAR SCREW
• B648C11545030FSD0: Acumen, 5.0 X 30mm, SELF-DRILLING, FIXED THORACOLUMBAR SCREW
• B648C11545025VST0: Acumen, 5.0 X 25mm, SELF-TAPPING, VARIABLE THORACOLUMBAR SCREW
• B648C11545025VSD0: Acumen, 5.0 X 25mm, SELF-DRILLING, VARIABLE THORACOLUMBAR SCREW
• B648C11545025FST0: Acumen, 5.0 X 25mm, SELF-TAPPING, FIXED THORACOLUMBAR SCREW
• B648C11545025FSD0: Acumen, 5.0 X 25mm, SELF-DRILLING, FIXED THORACOLUMBAR SCREW
• B648C11545020VST0: Acumen, 5.0 X 20mm, SELF-TAPPING, VARIABLE THORACOLUMBAR SCREW
• B648C11545020VSD0: Acumen, 5.0 X 20mm, SELF-DRILLING, VARIABLE THORACOLUMBAR SCREW
• B648C11545020FST0: Acumen, 5.0 X 20mm, SELF-TAPPING, FIXED THORACOLUMBAR SCREW
• B648C11545020FSD0: Acumen, 5.0 X 20mm, SELF-DRILLING, FIXED THORACOLUMBAR SCREW
• B648C11540432SR0: Acumen, THORACOLUMBAR PLATE, FOUR HOLE, SACRAL WITH RIDGE, FLAT, 32mm
• B648C11540432S0: Acumen, THORACOLUMBAR PLATE, FOUR HOLE, SACRAL, FLAT, 32mm
• B648C115404320: Acumen, THORACOLUMBAR PLATE, FOUR HOLE, 32mm
• B648C11540430SR0: Acumen, THORACOLUMBAR PLATE, FOUR HOLE, SACRAL WITH RIDGE, FLAT, 30mm
• B648C11540430S0: Acumen, THORACOLUMBAR PLATE, FOUR HOLE, SACRAL, FLAT, 30mm
• B648C115404300: Acumen, THORACOLUMBAR PLATE, FOUR HOLE, 30mm
• B648C11540428SR0: Acumen, THORACOLUMBAR PLATE, FOUR HOLE, SACRAL WITH RIDGE, FLAT, 28mm