Orthosis, Spine, Plate, Laminoplasty, Metal
2.0MM TI Cortex Screw SLF-Tpng With Stardrive(TM) Recess 6MM
1manufacturer
23catalogue numbers in this listing
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 | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | NQW |
| Device type | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K032534 |
| Record published | 2015-09-14 |
| Record revised | 2025-11-20 (version 6) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 443.182 | In distribution | |
| 443.166 | In distribution | |
| 401.356.99 | In distribution | |
| 401.362.99 | In distribution | |
| 443.170 | In distribution | |
| 443.172 | In distribution | |
| 401.358.99 | In distribution | |
| 443.164 | In distribution | |
| 401.386.99 | In distribution | |
| 443.180 | In distribution | |
| 443.178 | In distribution | |
| 401.136.99 | In distribution | |
| 401.392.99 | In distribution | |
| 401.134.99 | In distribution | |
| 401.388.99 | In distribution | |
| 447.10.99 | In distribution | |
| 443.176 | In distribution | |
| 443.168 | In distribution | |
| 401.390.99 | In distribution | |
| 401.354.99 | In distribution | |
| 401.138.99 | In distribution | |
| 443.174 | In distribution | |
| 401.360.99 | 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 |
| Prowess Laminoplasty System | Curiteva, Inc. | 42 |
| Gallery Laminoplasty Fixation System | Highridge Medical, LLC | 40 |
| Leverage | Nuvasive, Inc. | 38 |
| Relieve | Globus Medical, Inc. | 28 |
Showing 12 of 19. All products under Orthosis, Spine, Plate, Laminoplasty, Metal
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.