| Primary Device ID | B648C6157000 |
| NIH Device Record Key | a189d9a6-abeb-40d2-be4b-1250d91229e0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SI-LUTION Sacroiliac Joint Fusion System |
| Version Model Number | C615-700 |
| 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 | |
| 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 |
| Outer Diameter | 7 Millimeter |
| Outer Diameter | 7 Millimeter |
| Outer Diameter | 7 Millimeter |
| Outer Diameter | 7 Millimeter |
| Outer Diameter | 7 Millimeter |
| Outer Diameter | 7 Millimeter |
| Outer Diameter | 7 Millimeter |
| Outer Diameter | 7 Millimeter |
| Outer Diameter | 7 Millimeter |
| Outer Diameter | 7 Millimeter |
| Outer Diameter | 7 Millimeter |
| Outer Diameter | 7 Millimeter |
| Outer Diameter | 7 Millimeter |
| Outer Diameter | 7 Millimeter |
| Outer Diameter | 7 Millimeter |
| Outer Diameter | 7 Millimeter |
| Outer Diameter | 7 Millimeter |
| Outer Diameter | 7 Millimeter |
| Outer Diameter | 7 Millimeter |
| Outer Diameter | 7 Millimeter |
| Outer Diameter | 7 Millimeter |
| Outer Diameter | 7 Millimeter |
| Outer Diameter | 7 Millimeter |
| Outer Diameter | 7 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B648C6157000 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B648C6157000]
Moist Heat or Steam Sterilization
[B648C6157000]
Moist Heat or Steam Sterilization
[B648C6157000]
Moist Heat or Steam Sterilization
[B648C6157000]
Moist Heat or Steam Sterilization
[B648C6157000]
Moist Heat or Steam Sterilization
[B648C6157000]
Moist Heat or Steam Sterilization
[B648C6157000]
Moist Heat or Steam Sterilization
[B648C6157000]
Moist Heat or Steam Sterilization
[B648C6157000]
Moist Heat or Steam Sterilization
[B648C6157000]
Moist Heat or Steam Sterilization
[B648C6157000]
Moist Heat or Steam Sterilization
[B648C6157000]
Moist Heat or Steam Sterilization
[B648C6157000]
Moist Heat or Steam Sterilization
[B648C6157000]
Moist Heat or Steam Sterilization
[B648C6157000]
Moist Heat or Steam Sterilization
[B648C6157000]
Moist Heat or Steam Sterilization
[B648C6157000]
Moist Heat or Steam Sterilization
[B648C6157000]
Moist Heat or Steam Sterilization
[B648C6157000]
Moist Heat or Steam Sterilization
[B648C6157000]
Moist Heat or Steam Sterilization
[B648C6157000]
Moist Heat or Steam Sterilization
[B648C6157000]
Moist Heat or Steam Sterilization
[B648C6157000]
Moist Heat or Steam Sterilization
[B648C6157000]
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 |
| B648C61495SC0 | Stabilization Cap, Static, 9.5mm |
| B648C61495KC0 | Stabilization Cap, Kinetic, 9.5mm |
| B648C61495700 | Sacroiliac Screw, Fully Threaded, 9.5 x 70mm |
| B648C61495650 | Sacroiliac Screw, Fully Threaded, 9.5 x 65mm |
| B648C61495600 | Sacroiliac Screw, Fully Threaded, 9.5 x 60mm |
| B648C61495550 | Sacroiliac Screw, Fully Threaded, 9.5 x 55mm |
| B648C61495500 | Sacroiliac Screw, Fully Threaded, 9.5 x 50mm |
| B648C61495450 | Sacroiliac Screw, Fully Threaded, 9.5 x 45mm |
| B648C61495400 | Sacroiliac Screw, Fully Threaded, 9.5 x 40mm |
| B648C61495350 | Sacroiliac Screw, Fully Threaded, 9.5 x 35mm |
| B648C61495300 | Sacroiliac Screw, Fully Threaded, 9.5 x 30mm |
| B648C61470SC0 | Stabilization Cap, Static, 7mm |
| B648C61470KC0 | Stabilization Cap, Kinetic, 7mm |
| B648C61470700 | Sacroiliac Screw, Fully Threaded, 7 x 70mm |
| B648C61470650 | Sacroiliac Screw, Fully Threaded, 7 x 65mm |
| B648C61470600 | Sacroiliac Screw, Fully Threaded, 7 x 60mm |
| B648C61470550 | Sacroiliac Screw, Fully Threaded, 7 x 55mm |
| B648C61470500 | Sacroiliac Screw, Fully Threaded, 7 x 50mm |
| B648C61470450 | Sacroiliac Screw, Fully Threaded, 7 x 45mm |
| B648C61470400 | Sacroiliac Screw, Fully Threaded, 7 x 40mm |
| B648C61470350 | Sacroiliac Screw, Fully Threaded, 7 x 35mm |
| B648C61470300 | Sacroiliac Screw, Fully Threaded, 7 x 30mm |
| B648C61412SC0 | Stabilization Cap, Static, 12mm |
| B648C61412KC0 | Stabilization Cap, Kinetic, 12mm |
| B648C61412700 | Sacroiliac Screw, Fully Threaded, 12 x 70mm |
| B648C61412650 | Sacroiliac Screw, Fully Threaded, 12 x 65mm |
| B648C61412600 | Sacroiliac Screw, Fully Threaded, 12 x 60mm |
| B648C61412550 | Sacroiliac Screw, Fully Threaded, 12 x 55mm |
| B648C61412500 | Sacroiliac Screw, Fully Threaded, 12 x 50mm |
| B648C61412450 | Sacroiliac Screw, Fully Threaded, 12 x 45mm |
| B648C61412400 | Sacroiliac Screw, Fully Threaded, 12 x 40mm |
| B648C61412350 | Sacroiliac Screw, Fully Threaded, 12 x 35mm |
| B648C61412300 | Sacroiliac Screw, Fully Threaded, 12 x 30mm |
| B648C6149570H0 | Sacroiliac Screw, Headless, 9.5 x 70mm |
| B648C6149565H0 | Sacroiliac Screw, Headless, 9.5 x 65mm |
| B648C6149560H0 | Sacroiliac Screw, Headless, 9.5 x 60mm |
| B648C6149555H0 | Sacroiliac Screw, Headless, 9.5 x 55mm |
| B648C6149550H0 | Sacroiliac Screw, Headless, 9.5 x 50mm |
| B648C6149545H0 | Sacroiliac Screw, Headless, 9.5 x 45mm |
| B648C6149540H0 | Sacroiliac Screw, Headless, 9.5 x 40mm |
| B648C6149535H0 | Sacroiliac Screw, Headless, 9.5 x 35mm |
| B648C6149530H0 | Sacroiliac Screw, Headless, 9.5 x 30mm |
| B648C6147070H0 | Sacroiliac Screw, Headless, 7 x 70mm |
| B648C6147065H0 | Sacroiliac Screw, Headless, 7 x 65mm |
| B648C6147060H0 | Sacroiliac Screw, Headless, 7 x 60mm |
| B648C6147055H0 | Sacroiliac Screw, Headless, 7 x 55mm |
| B648C6147050H0 | Sacroiliac Screw, Headless, 7 x 50mm |
| B648C6147045H0 | Sacroiliac Screw, Headless, 7 x 45mm |
| B648C6147040H0 | Sacroiliac Screw, Headless, 7 x 40mm |
| B648C6147035H0 | Sacroiliac Screw, Headless, 7 x 35mm |