| Primary Device ID | B648C10542308SD0 |
| NIH Device Record Key | 4c17b1c6-cafa-476d-b414-2d7f123c4a12 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prowess Laminoplasty System |
| Version Model Number | C1054-2308-SD |
| 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 | |
| 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 | 2.3 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 8 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B648C10542308SD0 [Primary] |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B648C10542308SD0]
Moist Heat or Steam Sterilization
[B648C10542308SD0]
Moist Heat or Steam Sterilization
[B648C10542308SD0]
Moist Heat or Steam Sterilization
[B648C10542308SD0]
Moist Heat or Steam Sterilization
[B648C10542308SD0]
Moist Heat or Steam Sterilization
[B648C10542308SD0]
Moist Heat or Steam Sterilization
[B648C10542308SD0]
Moist Heat or Steam Sterilization
[B648C10542308SD0]
Moist Heat or Steam Sterilization
[B648C10542308SD0]
Moist Heat or Steam Sterilization
[B648C10542308SD0]
Moist Heat or Steam Sterilization
[B648C10542308SD0]
Moist Heat or Steam Sterilization
[B648C10542308SD0]
Moist Heat or Steam Sterilization
[B648C10542308SD0]
Moist Heat or Steam Sterilization
[B648C10542308SD0]
Moist Heat or Steam Sterilization
[B648C10542308SD0]
Moist Heat or Steam Sterilization
[B648C10542308SD0]
Moist Heat or Steam Sterilization
[B648C10542308SD0]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-10 |
| Device Publish Date | 2024-01-02 |
| B648C1054404P0 | PEEK Spacer, 4mm |
| B648C10542304SD0 | Self-Drilling Screw, 2.3 x 4mm |
| B648C1054104N0 | Spacer Plate, Inline, 4mm |
| B648C1054412P0 | PEEK Spacer, 12mm |
| B648C1054410P0 | PEEK Spacer, 10mm |
| B648C1054408P0 | PEEK Spacer, 8mm |
| B648C1054406P0 | PEEK Spacer, 6mm |
| B648C10543SS0 | Hinge Plate, Side by Side |
| B648C10543N0 | Hinge Plate, Inline |
| B648C10542712ST0 | Self-Tapping Screw, 2.7 x 12mm |
| B648C10542710ST0 | Self-Tapping Screw, 2.7 x 10mm |
| B648C10542708ST0 | Self-Tapping Screw, 2.7 x 8mm |
| B648C10542706ST0 | Self-Tapping Screw, 2.7 x 6mm |
| B648C10542704ST0 | Self-Tapping Screw, 2.7 x 4mm |
| B648C10542312ST0 | Self-Tapping Screw, 2.3 x 12mm |
| B648C10542312SD0 | Self-Drilling Screw, 2.3 x 12mm |
| B648C10542310ST0 | Self-Tapping Screw, 2.3 x 10mm |
| B648C10542310SD0 | Self-Drilling Screw, 2.3 x 10mm |
| B648C10542308ST0 | Self-Tapping Screw, 2.3 x 8mm |
| B648C10542308SD0 | Self-Drilling Screw, 2.3 x 8mm |
| B648C10542306ST0 | Self-Tapping Screw, 2.3 x 6mm |
| B648C10542306SD0 | Self-Drilling Screw, 2.3 x 6mm |
| B648C10542304ST0 | Self-Tapping Screw, 2.3 x 4mm |
| B648C1054112SS0 | Spacer Plate, Side by Side, 12mm |
| B648C1054112N0 | Spacer Plate, Inline, 12mm |
| B648C1054110SS0 | Spacer Plate, Side by Side, 10mm |
| B648C1054110N0 | Spacer Plate, Inline, 10mm |
| B648C1054108SS0 | Spacer Plate, Side by Side, 8mm |
| B648C1054108N0 | Spacer Plate, Inline, 8mm |
| B648C1054106SS0 | Spacer Plate, Side by Side, 6mm |
| B648C1054106N0 | Spacer Plate, Inline, 6mm |
| B648C1054104SS0 | Spacer Plate, Side by Side, 4mm |
| B648C10558100 | IMPLANT PICKUP |
| B648C10558000 | PLATE-SPACER INSERTER |
| B648C10557000 | PLATE-SPACER ASSEMBLY BLOCK |
| B648C10556040 | 12mm SPACER TRIAL |
| B648C10556030 | 10mm SPACER TRIAL |
| B648C10556020 | 8mm SPACER TRIAL |
| B648C10556010 | 6mm SPACER TRIAL |
| B648C10556000 | 4mm SPACER TRIAL |
| B648C10555000 | SCREW DRIVER |
| B648C10554100 | 1.25 x 4MM FLAT END BONE AWL |
| B648C10554000 | 1.25 x 4MM BONE AWL |
| B648C1055300100 | 10mm DRILL |
| B648C1055300080 | 8mm DRILL |
| B648C1055300060 | 6mm DRILL |
| B648C1055300040 | 4mm DRILL |
| B648C10552100 | Plate Cutter |
| B648C10552000 | Plate Bender |
| B648C10551100 | LAMINA LIFTER |