| Primary Device ID | B648C115402160 |
| NIH Device Record Key | 5fc23f48-97e6-45f3-9608-aec2cf7e2536 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Acumen Thoracolumbar Plate System |
| Version Model Number | C1154-0216 |
| 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 |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B648C115402160 [Primary] |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B648C115402160]
Moist Heat or Steam Sterilization
[B648C115402160]
Moist Heat or Steam Sterilization
[B648C115402160]
Moist Heat or Steam Sterilization
[B648C115402160]
Moist Heat or Steam Sterilization
[B648C115402160]
Moist Heat or Steam Sterilization
[B648C115402160]
Moist Heat or Steam Sterilization
[B648C115402160]
Moist Heat or Steam Sterilization
[B648C115402160]
Moist Heat or Steam Sterilization
[B648C115402160]
Moist Heat or Steam Sterilization
[B648C115402160]
Moist Heat or Steam Sterilization
[B648C115402160]
Moist Heat or Steam Sterilization
[B648C115402160]
Moist Heat or Steam Sterilization
[B648C115402160]
Moist Heat or Steam Sterilization
[B648C115402160]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-08 |
| Device Publish Date | 2024-10-31 |
| 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 |