Blackbird HLS
Lamin,hinged HOOK,KICKSTAND,MINIPLATE,10
1manufacturer
55catalogue 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 | Choice Spine, LP |
|---|---|
| FDA product code | NQW |
| Device type | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| 510(k) | K173215 |
| Record published | 2018-01-31 |
| Record revised | 2025-11-20 (version 5) |
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 15.8 mm; outer diameter 2.4 to 2.8 mm; width 4 to 14 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LT50-R2804 | Length 4 mm | In distribution |
| LT50-0110 | In distribution | |
| LT50-0312 | Width 12 mm | In distribution |
| LT50-0006 | Length 6 mm | In distribution |
| L070-1021 | In distribution | |
| LT50-0112 | In distribution | |
| LT50-0014 | Length 14 mm | In distribution |
| LT50-D2404 | Outer Diameter 2.4 mm | In distribution |
| L070-1011 | In distribution | |
| LT50-0114 | In distribution | |
| LT50-0304 | Width 4 mm | In distribution |
| LT50-D2410 | Length 10 mm | In distribution |
| L070-1007 | In distribution | |
| L070-1006 | In distribution | |
| LT50-T2408 | Length 8 mm | In distribution |
| LT50-0210 | In distribution | |
| LT50-0106 | In distribution | |
| L070-1005 | In distribution | |
| L070-1009 | In distribution | |
| LT50-0104 | In distribution | |
| LT50-T2406 | Outer Diameter 2.4 mm | In distribution |
| L070-1003 | In distribution | |
| LT50-0212 | In distribution | |
| LT50-0314 | Width 14 mm | In distribution |
| L070-1020 | In distribution | |
| LT50-R2812 | Length 12 mm | In distribution |
| LT50-0010 | Length 10 mm | In distribution |
| L070-1002 | In distribution | |
| LT50-0012 | Length 12 mm | In distribution |
| LT50-0008 | Length 8 mm | In distribution |
| L070-1013 | In distribution | |
| LT50-H002 | In distribution | |
| LT50-0108 | In distribution | |
| LT50-0206 | In distribution | |
| LT50-R2808 | Outer Diameter 2.8 mm | In distribution |
| L070-1004 | In distribution | |
| LT50-D2408 | Length 8 mm | In distribution |
| LT50-0214 | In distribution | |
| L070-1008 | In distribution | |
| LT50-0004 | Length 4 mm | In distribution |
| LT50-T2410 | Outer Diameter 2.4 mm | In distribution |
| LT50-0306 | Width 6 mm | In distribution |
| L070-1012 | In distribution | |
| LT50-R2810 | Outer Diameter 2.8 mm | In distribution |
| LT50-0208 | In distribution | |
| LT50-D2406 | Outer Diameter 2.4 mm | In distribution |
| LT50-0308 | Width 8 mm | In distribution |
| LT50-0310 | Length 11.8 mm | In distribution |
| LT50-D2412 | Outer Diameter 2.4 mm | In distribution |
| L070-1001 | In distribution | |
| LT50-T2404 | Outer Diameter 2.4 mm | In distribution |
| LT50-H001 | In distribution | |
| LT50-T2412 | Outer Diameter 2.4 mm | In distribution |
| LT50-R2806 | Outer Diameter 2.8 mm | In distribution |
| L070-1010 | 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 |
| Prowess Laminoplasty System | Curiteva, Inc. | 42 |
| 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
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.