| Primary Device ID | B648C5151000 |
| NIH Device Record Key | 8009473c-bf3b-4e21-ad3f-39c68a5b38a7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prodigy Pedicle Screw System |
| Version Model Number | C515-100 |
| 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 | 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 |
| 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 | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B648C5151000 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B648C5151000]
Moist Heat or Steam Sterilization
[B648C5151000]
Moist Heat or Steam Sterilization
[B648C5151000]
Moist Heat or Steam Sterilization
[B648C5151000]
Moist Heat or Steam Sterilization
[B648C5151000]
Moist Heat or Steam Sterilization
[B648C5151000]
Moist Heat or Steam Sterilization
[B648C5151000]
Moist Heat or Steam Sterilization
[B648C5151000]
Moist Heat or Steam Sterilization
[B648C5151000]
Moist Heat or Steam Sterilization
[B648C5151000]
Moist Heat or Steam Sterilization
[B648C5151000]
Moist Heat or Steam Sterilization
[B648C5151000]
Moist Heat or Steam Sterilization
[B648C5151000]
Moist Heat or Steam Sterilization
[B648C5151000]
Moist Heat or Steam Sterilization
[B648C5151000]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-15 |
| Device Publish Date | 2024-01-05 |
| B648C524R55150C0 | Curved MIS Rod, 5.5 x 150mm |
| B648C524R55130C0 | Curved MIS Rod, 5.5 x 130mm |
| B648C524R55120C0 | Curved MIS Rod, 5.5 x 120mm |
| B648C524R55110C0 | Curved MIS Rod, 5.5 x 110mm |
| B648C524R55100C0 | Curved MIS Rod, 5.5 x 100mm |
| B648C524R55090C0 | Curved MIS Rod, 5.5 x 90mm |
| B648C524R55080C0 | Curved MIS Rod, 5.5 x 80mm |
| B648C524R55070C0 | Curved MIS Rod, 5.5 x 70mm |
| B648C524R55065C0 | Curved MIS Rod, 5.5 x 65mm |
| B648C524R55060C0 | Curved MIS Rod, 5.5 x 60mm |
| B648C524R55055C0 | Curved MIS Rod, 5.5 x 55mm |
| B648C524R55050C0 | Curved MIS Rod, 5.5 x 50mm |
| B648C524R55045C0 | Curved MIS Rod, 5.5 x 45mm |
| B648C524R55040C0 | Curved MIS Rod, 5.5 x 40mm |
| B648C524R55035C0 | Curved MIS Rod, 5.5 x 35mm |
| B648C524R55030C0 | Curved MIS Rod, 5.5 x 30mm |
| B648C52475550 | MIS Pedicle Screw, 7.5 x 55mm |
| B648C52475500 | MIS Pedicle Screw, 7.5 x 50mm |
| B648C52475450 | MIS Pedicle Screw, 7.5 x 45mm |
| B648C52475400 | MIS Pedicle Screw, 7.5 x 40mm |
| B648C52475350 | MIS Pedicle Screw, 7.5 x 35mm |
| B648C52475300 | MIS Pedicle Screw, 7.5 x 30mm |
| B648C52465550 | MIS Pedicle Screw, 6.5 x 55mm |
| B648C52465500 | MIS Pedicle Screw, 6.5 x 50mm |
| B648C52465450 | MIS Pedicle Screw, 6.5 x 45mm |
| B648C52465400 | MIS Pedicle Screw, 6.5 x 40mm |
| B648C52465350 | MIS Pedicle Screw, 6.5 x 35mm |
| B648C52465300 | MIS Pedicle Screw, 6.5 x 30mm |
| B648C52455550 | MIS Pedicle Screw, 5.5 x 55mm |
| B648C52455500 | MIS Pedicle Screw, 5.5 x 50mm |
| B648C52455450 | MIS Pedicle Screw, 5.5 x 45mm |
| B648C52455400 | MIS Pedicle Screw, 5.5 x 40mm |
| B648C52455350 | MIS Pedicle Screw, 5.5 x 35mm |
| B648C52455300 | MIS Pedicle Screw, 5.5 x 30mm |
| B648C524R554000 | Straight MIS Rod, 5.5 x 400mm |
| B648C524R553000 | Straight MIS Rod, 5.5 x 300mm |
| B648C524R55200C0 | Curved MIS Rod, 5.5 x 200mm |
| B648C524R55180C0 | Curved MIS Rod, 5.5 x 180mm |
| B648C524R55175C0 | Curved MIS Rod, 5.5 x 175mm |
| B648C524R55170C0 | Curved MIS Rod, 5.5 x 170mm |
| B648C524R55165C0 | Curved MIS Rod, 5.5 x 165mm |
| B648C524R55160C0 | Curved MIS Rod, 5.5 x 160mm |
| B648C524R55155C0 | Curved MIS Rod, 5.5 x 155mm |
| B648C524R55075C0 | Curved MIS Rod, 5.5 x 75mm |
| B648C52475600 | MIS Pedicle Screw, 7.5 x 60mm |
| B648C5247555DT0 | Dual Thread Extended Top Pedicle Screw, 7.5 x 55mm |
| B648C5247550DT0 | Dual Thread Extended Top Pedicle Screw, 7.5 x 50mm |
| B648C5247545DT0 | Dual Thread Extended Top Pedicle Screw, 7.5 x 45mm |
| B648C5247540DT0 | Dual Thread Extended Top Pedicle Screw, 7.5 x 40mm |
| B648C5247535DT0 | Dual Thread Extended Top Pedicle Screw, 7.5 x 35mm |