Canopy
CANOPY Polyaxial Screw Hole Plate, 2.5mm Offset, Right, 11mm
1manufacturer
65catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Globus Medical, Inc., United States |
|---|---|
| FDA product code | NQW |
| Device type | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K121732 |
| Record published | 2015-11-06 |
| 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 |
| Label carries | lot or batch number |
| Sizes | Height 5 to 13 mm; outer diameter 2.6 to 3 mm; length 4 to 12 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3102.6009 | Height 9 mm | In distribution |
| 1102.5113 | In distribution | |
| 1102.5005 | Height 5 mm | In distribution |
| 1102.6010 | Outer Diameter 2.6 mm | In distribution |
| 1102.5007 | Height 7 mm | In distribution |
| 1102.8008 | Length 8 mm | In distribution |
| 1102.3111 | In distribution | |
| 1102.5013 | Height 13 mm | In distribution |
| 1102.1005 | Height 5 mm | In distribution |
| 1102.1007 | Height 7 mm | In distribution |
| 1102.3107 | In distribution | |
| 1102.8010 | Outer Diameter 3 mm | In distribution |
| 1102.6004 | Outer Diameter 2.6 mm | In distribution |
| 1102.4005 | Height 5 mm | In distribution |
| 1102.5111 | In distribution | |
| 1102.8004 | Length 4 mm | In distribution |
| 1102.3113 | In distribution | |
| 1102.8006 | Length 6 mm | In distribution |
| 1102.3005 | Height 5 mm | In distribution |
| 1102.2013 | Height 13 mm | In distribution |
| 1102.2005 | Height 5 mm | In distribution |
| 1102.4011 | Height 11 mm | In distribution |
| 1102.5109 | In distribution | |
| 1102.3007 | Height 7 mm | In distribution |
| 1102.3211 | In distribution | |
| 1102.4013 | Height 13 mm | In distribution |
| 1102.7001 | In distribution | |
| 1102.3011 | Height 11 mm | In distribution |
| 1102.3009 | Height 9 mm | In distribution |
| 3102.6007 | Height 7 mm | In distribution |
| 1102.3207 | In distribution | |
| 1102.5107 | In distribution | |
| 1102.5207 | In distribution | |
| 1102.4007 | Height 7 mm | In distribution |
| 1102.3209 | In distribution | |
| 1102.5011 | Height 11 mm | In distribution |
| 1102.5211 | In distribution | |
| 1102.3205 | In distribution | |
| 1102.3105 | In distribution | |
| 1102.1009 | Height 9 mm | In distribution |
| 1102.5009 | Height 9 mm | In distribution |
| 1102.6008 | Length 8 mm | In distribution |
| 3102.6013 | Height 13 mm | In distribution |
| 1102.8012 | Outer Diameter 3 mm | In distribution |
| 1102.3109 | In distribution | |
| 1102.8005 | Outer Diameter 3 mm | In distribution |
| 1102.3213 | In distribution | |
| 1102.6005 | Length 5 mm | In distribution |
| 1102.5205 | In distribution | |
| 1102.6012 | Outer Diameter 2.6 mm | In distribution |
| 1102.2011 | Height 11 mm | In distribution |
| 1102.5213 | In distribution | |
| 1102.6006 | Length 6 mm | In distribution |
| 3102.6005 | Height 5 mm | In distribution |
| 1102.5105 | In distribution | |
| 1102.4009 | Height 9 mm | In distribution |
| 1102.7000 | In distribution | |
| 1102.5209 | In distribution | |
| 3102.6011 | Height 11 mm | In distribution |
| 1102.3013 | Height 13 mm | In distribution |
| 1102.2009 | Height 9 mm | In distribution |
| 1102.1013 | Height 13 mm | In distribution |
| 1102.1011 | Height 11 mm | In distribution |
| 1102.2007 | Height 7 mm | In distribution |
| 1102.9000 | 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 |
| 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 |
| Camber | Nuvasive, Inc. | 27 |
Showing 12 of 19. All products under Orthosis, Spine, Plate, Laminoplasty, Metal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K171413 | 2017-07-14 |
| K121732 | 2012-10-31 |
| K080664 | 2008-07-25 |
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.