Leverage
LeVerage Plate, 12.5mm Traditional M-L
1manufacturer
38catalogue numbers in this listing
1510(k) clearance
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 | Nuvasive, Inc., United States |
|---|---|
| FDA product code | NQW |
| Device type | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K091623 |
| Record published | 2015-10-24 |
| Record revised | 2025-06-11 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7650409 | In distribution | |
| 7650508P | In distribution | |
| 7650506 | In distribution | |
| 7650312 | In distribution | |
| 7650009 | In distribution | |
| 7650805 | In distribution | |
| 7650108 | In distribution | |
| 7650111 | In distribution | |
| 7650608P | In distribution | |
| 7650506P | In distribution | |
| 7650011 | In distribution | |
| 7650411 | In distribution | |
| 7650505P | In distribution | |
| 7650408 | In distribution | |
| 7650606P | In distribution | |
| 7650208 | In distribution | |
| 7650311 | In distribution | |
| 7650309 | In distribution | |
| 7650705 | In distribution | |
| 7650507P | In distribution | |
| 7650605 | In distribution | |
| 7650412 | In distribution | |
| 7650507 | In distribution | |
| 7650212 | In distribution | |
| 7650112 | In distribution | |
| 7650605P | In distribution | |
| 7650008 | In distribution | |
| 7650308 | In distribution | |
| 7650607 | In distribution | |
| 7650606 | In distribution | |
| 7650211 | In distribution | |
| 7650012 | In distribution | |
| 7650608 | In distribution | |
| 7650607P | In distribution | |
| 7650209 | In distribution | |
| 7650109 | In distribution | |
| 7650508 | In distribution | |
| 7650505 | 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 |
| 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 |
|---|---|
| K091623 | 2009-10-09 |
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.