Camber
Camber Trad Plate, 14mm Lg Lamina M-L
1manufacturer
27catalogue 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) | K191169 |
| Record published | 2020-08-25 |
| Record revised | 2025-11-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation 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 |
|---|---|---|
| 8370028P | In distribution | |
| 8370025P | In distribution | |
| 8370029P | In distribution | |
| 8370027P | In distribution | |
| 8370023P | In distribution | |
| 8370012P | In distribution | |
| 8370032P | In distribution | |
| 8370024P | In distribution | |
| 8370022P | In distribution | |
| 8370017P | In distribution | |
| 8370033P | In distribution | |
| 8370019P | In distribution | |
| 8370036P | In distribution | |
| 8370011P | In distribution | |
| 8370016P | In distribution | |
| 8370021P | In distribution | |
| 8370031P | In distribution | |
| 8370013P | In distribution | |
| 8370037P | In distribution | |
| 8370020P | In distribution | |
| 8370014P | In distribution | |
| 8370026P | In distribution | |
| 8370015P | In distribution | |
| 8370034P | In distribution | |
| 8370030P | In distribution | |
| 8370035P | In distribution | |
| 8370018P | 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
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.