Mountaineer
MOUNTAINEER LAMINOPLASTY SYSTEM INLINE SIDE-BY-SIDE PLATE 12mm
1manufacturer
25catalogue 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 | Medos International Sàrl, Switzerland |
|---|---|
| FDA product code | NQW |
| Device type | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| 510(k) | K091994 |
| Record published | 2015-09-24 |
| Record revised | 2025-11-20 (version 7) |
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 |
| Distribution end date | 2019-01-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 188370306 | Withdrawn | |
| 188370104 | Withdrawn | |
| 188370200 | Withdrawn | |
| 188370008 | Withdrawn | |
| 188370312 | Withdrawn | |
| 188370308 | Withdrawn | |
| 188370310 | Withdrawn | |
| 188370410 | Withdrawn | |
| 188370418 | Withdrawn | |
| 188370110 | Withdrawn | |
| 188370112 | Withdrawn | |
| 188370414 | Withdrawn | |
| 188370318 | Withdrawn | |
| 188370406 | Withdrawn | |
| 188370006 | Withdrawn | |
| 188370004 | Withdrawn | |
| 188370012 | Withdrawn | |
| 188370408 | Withdrawn | |
| 188370106 | Withdrawn | |
| 188370412 | Withdrawn | |
| 188370314 | Withdrawn | |
| 188370010 | Withdrawn | |
| 188370316 | Withdrawn | |
| 188370108 | Withdrawn | |
| 188370416 | Withdrawn |
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.