Gallery Laminoplasty Fixation System
Gallery 16MM Plate With Hook
1manufacturer
40catalogue 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 | Highridge Medical, LLC, 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, Manufacturer |
| Record published | 2025-11-15 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-523090 | Device Size Text, specify—GALLERY 2.0X5MM S-D SCREW | In distribution |
| 14-523075 | Device Size Text, specify—GALLERY 2.0X5MM S-T SCREW | In distribution |
| 14-523100 | Device Size Text, specify—GALLERY 2.8X5MM S-D SCREW | In distribution |
| 14-523081 | Device Size Text, specify—GALLERY 2.4X7MM S-T SCREW | In distribution |
| 14-523079 | Device Size Text, specify—GALLERY 2.0X13MM S-T SCREW | In distribution |
| 14-523101 | Device Size Text, specify—GALLERY 2.8X7MM S-D SCREW | In distribution |
| 14-523102 | Device Size Text, specify—GALLERY 2.8X9MM S-D SCREW | In distribution |
| 14-523236 | Device Size Text, specify—GALLERY 16MM PLATE WITH HOOK | In distribution |
| 14-523234 | Device Size Text, specify—GALLERY 14MM PLATE WITH HOOK | In distribution |
| 14-523083 | Device Size Text, specify—GALLERY 2.4X11MM S-T SCREW | In distribution |
| 14-523094 | Device Size Text, specify—GALLERY 2.0X13MM S-D SCREW | In distribution |
| 14-523232 | Device Size Text, specify—GALLERY 12MM PLATE WITH HOOK | In distribution |
| 14-523088 | Device Size Text, specify—GALLERY 2.8X11MM S-T SCREW | In distribution |
| 14-523099 | Device Size Text, specify—GALLERY 2.4X13MM S-D SCREW | In distribution |
| 14-523082 | Device Size Text, specify—GALLERY 2.4X9MM S-T SCREW | In distribution |
| 14-523095 | Device Size Text, specify—GALLERY 2.4X5MM S-D SCREW | In distribution |
| 14-523103 | Device Size Text, specify—GALLERY 2.8X11MM S-D SCREW | In distribution |
| 14-523077 | Device Size Text, specify—GALLERY 2.0X9MM S-T SCREW | In distribution |
| 14-523210 | Device Size Text, specify—GALLERY 10MM STANDARD PLATE | In distribution |
| 14-523086 | Device Size Text, specify—GALLERY 2.8X7MM S-T SCREW | In distribution |
| 14-523097 | Device Size Text, specify—GALLERY 2.4X9MM S-D SCREW | In distribution |
| 14-523214 | Device Size Text, specify—GALLERY 14MM STANDARD PLATE | In distribution |
| 14-523078 | Device Size Text, specify—GALLERY 2.0X11MM S-T SCREW | In distribution |
| 14-523230 | Device Size Text, specify—GALLERY 10MM PLATE WITH HOOK | In distribution |
| 14-523091 | Device Size Text, specify—GALLERY 2.0X7MM S-D SCREW | In distribution |
| 14-523085 | Device Size Text, specify—GALLERY 2.8X5MM S-T SCREW | In distribution |
| 14-523093 | Device Size Text, specify—GALLERY 2.0X11MM S-D SCREW | In distribution |
| 14-523104 | Device Size Text, specify—GALLERY 2.8X13MM S-D SCREW | In distribution |
| 14-523080 | Device Size Text, specify—GALLERY 2.4X5MM S-T SCREW | In distribution |
| 14-523212 | Device Size Text, specify—GALLERY 12MM STANDARD PLATE | In distribution |
| 14-523084 | Device Size Text, specify—GALLERY 2.4X13MM S-T SCREW | In distribution |
| 14-523089 | Device Size Text, specify—GALLERY 2.8X13MM S-T SCREW | In distribution |
| 14-523096 | Device Size Text, specify—GALLERY 2.4X7MM S-D SCREW | In distribution |
| 14-523092 | Device Size Text, specify—GALLERY 2.0X9MM S-D SCREW | In distribution |
| 14-523087 | Device Size Text, specify—GALLERY 2.8X9MM S-T SCREW | In distribution |
| 14-523228 | Device Size Text, specify—GALLERY 8MM PLATE WITH HOOK | In distribution |
| 14-523208 | Device Size Text, specify—GALLERY 8MM STANDARD PLATE | In distribution |
| 14-523216 | Device Size Text, specify—GALLERY 16MM STANDARD PLATE | In distribution |
| 14-523076 | Device Size Text, specify—GALLERY 2.0X7MM S-T SCREW | In distribution |
| 14-523098 | Device Size Text, specify—GALLERY 2.4X11MM S-D SCREW | 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 |
| 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.