Prowess Laminoplasty System
SIDE-BY-SIDE LARGE HOOK PLATE, 10mm
1manufacturer
42catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Curiteva, Inc., United States |
|---|---|
| FDA product code | NQW |
| Device type | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K231232 |
| Record published | 2025-08-18 |
| Record revised | 2025-11-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 4 to 12 mm; outer diameter 2.3 to 2.7 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C1054-210-6-SS | Length 10 mm | In distribution |
| C1054-106-N | Length 6 mm | In distribution |
| C1054-112-SS | Length 12 mm | In distribution |
| C1054-208-6-SS | Length 8 mm | In distribution |
| C1054-2710-ST | Outer Diameter 2.7 mm | In distribution |
| C1054-110-N | Length 10 mm | In distribution |
| C1054-104-N | Length 4 mm | In distribution |
| C1054-2704-ST | Outer Diameter 2.7 mm | In distribution |
| C1054-204-6-N | Length 4 mm | In distribution |
| C1054-2310-SD | Outer Diameter 2.3 mm | In distribution |
| C1054-2708-ST | Outer Diameter 2.7 mm | In distribution |
| C1054-206-6-N | Length 6 mm | In distribution |
| C1054-2304-ST | Outer Diameter 2.3 mm | In distribution |
| C1054-3-SS | In distribution | |
| C1054-210-6-N | Length 10 mm | In distribution |
| C1054-2310-ST | Outer Diameter 2.3 mm | In distribution |
| C1054-406-P | Length 6 mm | In distribution |
| C1054-204-6-SS | Length 4 mm | In distribution |
| C1054-410-P | Length 10 mm | In distribution |
| C1054-2706-ST | Outer Diameter 2.7 mm | In distribution |
| C1054-112-N | Length 12 mm | In distribution |
| C1054-206-6-SS | Length 6 mm | In distribution |
| C1054-106-SS | Length 6 mm | In distribution |
| C1054-2306-ST | Outer Diameter 2.3 mm | In distribution |
| C1054-404-P | Length 4 mm | In distribution |
| C1054-2712-ST | Outer Diameter 2.7 mm | In distribution |
| C1054-212-6-SS | Length 12 mm | In distribution |
| C1054-108-N | Length 8 mm | In distribution |
| C1054-110-SS | Length 10 mm | In distribution |
| C1054-108-SS | Length 8 mm | In distribution |
| C1054-2308-ST | Outer Diameter 2.3 mm | In distribution |
| C1054-2304-SD | Outer Diameter 2.3 mm | In distribution |
| C1054-104-SS | Length 4 mm | In distribution |
| C1054-212-6-N | Length 12 mm | In distribution |
| C1054-412-P | Length 12 mm | In distribution |
| C1054-2312-ST | Outer Diameter 2.3 mm | In distribution |
| C1054-208-6-N | Length 8 mm | In distribution |
| C1054-2312-SD | Outer Diameter 2.3 mm | In distribution |
| C1054-408-P | Length 8 mm | In distribution |
| C1054-2306-SD | Outer Diameter 2.3 mm | In distribution |
| C1054-2308-SD | Outer Diameter 2.3 mm | In distribution |
| C1054-3-N | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Xspan Laminoplasty Fixation System | Xtant Medical Holdings, Inc. | 265 |
| Hinged Laminoplasty | Life Spine | 129 |
| Laminoplasty | Seaspine Orthopedics Corporation | 104 |
| Release® Laminoplasty Fixation System | Pioneer Surgical Technology, Inc. | 88 |
| Gallery Laminoplasty System | Biomet Spine | 80 |
| Canopy | Globus Medical, Inc. | 65 |
| Centerpiece™ Plate Fixation System | Medtronic Sofamor Danek, Inc. | 61 |
| Blackbird HLS | Choice Spine, LP | 55 |
| Gallery Laminoplasty Fixation System | Highridge Medical, LLC | 40 |
| Leverage | Nuvasive, Inc. | 38 |
| Relieve | Globus Medical, Inc. | 28 |
| Camber | Nuvasive, Inc. | 27 |
Showing 12 of 19. All products under Orthosis, Spine, Plate, Laminoplasty, Metal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243137 | 2024-10-28 |
| K231232 | 2023-06-28 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.