Xspan Laminoplasty Fixation System
10mm PLATE, LAMINOPLASTY, INLINE, with HOOK & FIN, 4mm THROAT, SPECIAL SLOT
1manufacturer
265catalogue 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 | Xtant Medical Holdings, 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 |
| 510(k) | K160114 |
| Record published | 2016-04-08 |
| Record revised | 2025-11-20 (version 7) |
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 |
| Sizes | Length 5 to 12 mm; depth 4 to 6 mm; outer diameter 2.6 to 3 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X085-0306-H04-LU-STR | Length 6 mm | In distribution |
| X085-0110-SP-STR | Length 10 mm | In distribution |
| X085-0106-F04-SP | Length 6 mm | In distribution |
| X085-0206-H04-STR | Depth 4 mm | In distribution |
| X085-0312-H06-R-STR | Depth 6 mm | In distribution |
| X085-0312-H04-R-STR | Length 12 mm | In distribution |
| X085-0110-F06-U | Depth 6 mm | In distribution |
| X085-0310-F04-L-STR | Length 10 mm | In distribution |
| X085-2608 | Outer Diameter 2.6 mm | In distribution |
| X085-2606 | Outer Diameter 2.6 mm | In distribution |
| X085-0150 | In distribution | |
| X085-0212-F06-STR | Depth 6 mm | In distribution |
| X085-0106-H04-SP-STR | Length 6 mm | In distribution |
| X085-0308-H04-RU-STR | Depth 4 mm | In distribution |
| X085-0110-F04-SP | Depth 4 mm | In distribution |
| X085-0106-U | Length 6 mm | In distribution |
| X085-0306-H06-L | Length 6 mm | In distribution |
| X085-0306-H04-L | Length 6 mm | In distribution |
| X085-0306-F04-R | Length 6 mm | In distribution |
| X085-0112 | Length 12 mm | In distribution |
| X085-0206-H04 | Length 6 mm | In distribution |
| X085-0310-H04-RU-STR | Length 10 mm | In distribution |
| X085-0208-STR | Length 8 mm | In distribution |
| X085-0312-H04-LU | Length 12 mm | In distribution |
| X085-0112-F06-STR | Depth 6 mm | In distribution |
| X085-0312-H04-LU-STR | Length 12 mm | In distribution |
| X085-0310-H06-LU-STR | Length 10 mm | In distribution |
| X085-0310-H04-L | Depth 4 mm | In distribution |
| X085-0110-F06 | Length 10 mm | In distribution |
| X085-0306-H06-RU | Length 6 mm | In distribution |
| X085-3007 | Outer Diameter 3 mm | In distribution |
| X085-0001 | In distribution | |
| X085-0110-H04-STR | Depth 4 mm | In distribution |
| X085-0108-SP | Length 8 mm | In distribution |
| X085-0306-H04-L-STR | Depth 4 mm | In distribution |
| X085-0312-F06-R-STR | Length 12 mm | In distribution |
| X085-0308-H06-RU | Depth 6 mm | In distribution |
| X085-0212-H06-STR | Length 12 mm | In distribution |
| X085-0106-H06-STR | Length 6 mm | In distribution |
| X085-3006 | Outer Diameter 3 mm | In distribution |
| X085-0112-F06 | Length 12 mm | In distribution |
| X085-2607 | Outer Diameter 2.6 mm | In distribution |
| X085-0306-H04-RU | Length 6 mm | In distribution |
| X085-0212-H04-STR | Depth 4 mm | In distribution |
| X085-3009-STR | Outer Diameter 3 mm | In distribution |
| X085-0108-F06-STR | Depth 6 mm | In distribution |
| X085-0306-H04-LU | Depth 4 mm | In distribution |
| X085-0110-F04-U | Length 10 mm | In distribution |
| X085-0208-H04-STR | Depth 4 mm | In distribution |
| X085-0310-H06-R | Depth 6 mm | In distribution |
| X085-0308-H06-LU-STR | Length 8 mm | In distribution |
| X085-0312-F04-L | Length 12 mm | In distribution |
| X085-0106-F04-STR | Length 6 mm | In distribution |
| X085-0310-H04-L-STR | Length 10 mm | In distribution |
| X085-0110-F04 | Length 10 mm | In distribution |
| X085-0208 | Length 8 mm | In distribution |
| X085-0312-H06-LU | Length 12 mm | In distribution |
| X085-0306-H06-R-STR | Depth 6 mm | In distribution |
| X085-0210 | Length 10 mm | In distribution |
| X085-0108-H04-STR | Length 8 mm | In distribution |
| X085-0112-F06-U | Depth 6 mm | In distribution |
| X085-0110-F06-STR | Length 10 mm | In distribution |
| X085-0108-F04-U-STR | Length 8 mm | In distribution |
| X085-0106-SP | Length 6 mm | In distribution |
| X085-0112-F04-STR | Depth 4 mm | In distribution |
| X085-0112-H04 | Length 12 mm | In distribution |
| X085-0110-F06-U-STR | Length 10 mm | In distribution |
| X085-0306-H06-R | Length 6 mm | In distribution |
| X085-0310-F06-R-STR | Depth 6 mm | In distribution |
| X085-0308-H06-RU-STR | Depth 6 mm | In distribution |
| X085-0206-F06 | Length 6 mm | In distribution |
| X085-0206-F04-STR | Length 6 mm | In distribution |
| X085-2605 | Length 5 mm | In distribution |
| X085-0108-F04-SP-STR | Length 8 mm | In distribution |
| X085-0308-H04-R | Depth 4 mm | In distribution |
| X085-0112-U | Length 12 mm | In distribution |
| X085-0306-H06-RU-STR | Length 6 mm | In distribution |
| X085-0208-F04-STR | Depth 4 mm | In distribution |
| X085-0306-F06-L | Depth 6 mm | In distribution |
| X085-0210-F06-STR | Length 10 mm | In distribution |
| X085-0108-F06-U | Depth 6 mm | In distribution |
| X085-2606-STR | Outer Diameter 2.6 mm | In distribution |
| X085-0310-H04-LU-STR | Length 10 mm | In distribution |
| X085-0112-H06-SP | Depth 6 mm | In distribution |
| X085-0312-F06-L | Length 12 mm | In distribution |
| X085-0112-H06-STR | Length 12 mm | In distribution |
| X085-0310-H04-RU | Length 10 mm | In distribution |
| X085-0308-H06-L-STR | Length 8 mm | In distribution |
| X085-0110-H04-SP-STR | Length 10 mm | In distribution |
| X085-0112-F04-U-STR | Depth 4 mm | In distribution |
| T085-0050 | In distribution | |
| X085-0210-H04 | Length 10 mm | In distribution |
| X085-0308-H04-LU | Length 8 mm | In distribution |
| X085-0212-H04 | Depth 4 mm | In distribution |
| X085-0308-H06-L | Length 8 mm | In distribution |
| X085-0110-F06-SP | Depth 6 mm | In distribution |
| X085-0112-F04-SP | Length 12 mm | In distribution |
| X085-0112-F06-U-STR | Depth 6 mm | In distribution |
| X085-0108-F04-U | Depth 4 mm | In distribution |
| X085-0208-H04 | Depth 4 mm | In distribution |
| X085-0310-H06-LU | Length 10 mm | In distribution |
| X085-0308-H04-RU | Length 8 mm | In distribution |
| X085-0312-F06-R | Length 12 mm | In distribution |
| X085-0312-H04-L-STR | Depth 4 mm | In distribution |
| X085-0312-F04-R | Depth 4 mm | In distribution |
| X085-0308-F04-L-STR | Depth 4 mm | In distribution |
| X085-0210-F04-STR | Length 10 mm | In distribution |
| X085-0106-F06-STR | Depth 6 mm | In distribution |
| X085-0108-H06-SP-STR | Depth 6 mm | In distribution |
| X085-0312-F04-L-STR | Length 12 mm | In distribution |
| X085-0310-F06-L-STR | Length 10 mm | In distribution |
| X085-0108-F06-U-STR | Depth 6 mm | In distribution |
| X085-0110-H06-STR | Length 10 mm | In distribution |
| X085-0108-STR | Length 8 mm | In distribution |
| X085-0110-H06 | Length 10 mm | In distribution |
| X085-0308-F04-R-STR | In distribution | |
| X085-0108-H06-SP | Depth 6 mm | In distribution |
| X085-0310-H04-R-STR | Length 10 mm | In distribution |
| X085-0106-F04-SP-STR | Length 6 mm | In distribution |
| X085-0110-F04-U-STR | Length 10 mm | In distribution |
| X085-0310-H04-R | Depth 4 mm | In distribution |
| X085-0110-H04 | Length 10 mm | In distribution |
| X085-3009 | Outer Diameter 3 mm | In distribution |
| X085-0108-F06 | Length 8 mm | In distribution |
| X085-0312-H06-RU | Length 12 mm | In distribution |
| X085-3005-STR | Length 5 mm | In distribution |
| X085-0312-H04-L | Length 12 mm | In distribution |
| X085-0106-SP-STR | Length 6 mm | In distribution |
| X085-0308-H04-LU-STR | Length 8 mm | In distribution |
| X085-2609 | Length 9 mm | In distribution |
| X085-2605-STR | Length 5 mm | In distribution |
| X085-0212-H06 | Length 12 mm | In distribution |
| X085-0106-F06-U | Depth 6 mm | In distribution |
| X085-0306-F04-R-STR | Depth 4 mm | In distribution |
| X085-0306-H06-LU-STR | Length 6 mm | In distribution |
| X085-0112-U-STR | Length 12 mm | In distribution |
| X085-0206-STR | Length 6 mm | In distribution |
| X085-0110-F04-SP-STR | Length 10 mm | In distribution |
| X085-0310-F04-R | Depth 4 mm | In distribution |
| X085-0108-F06-SP | Depth 6 mm | In distribution |
| X085-0112-F04-U | Length 12 mm | In distribution |
| X085-0306-F04-L | Depth 4 mm | In distribution |
| X085-0108-F04-STR | Depth 4 mm | In distribution |
| X085-0106-U-STR | Length 6 mm | In distribution |
| X085-0110 | Length 10 mm | In distribution |
| X085-0112-STR | Length 12 mm | In distribution |
| X085-0106-F04-U | Length 6 mm | In distribution |
| X085-0306-F06-L-STR | Length 6 mm | In distribution |
| X085-0206-F04 | Length 6 mm | In distribution |
| X085-3005 | Length 5 mm | In distribution |
| X085-0310-H04-LU | Depth 4 mm | In distribution |
| X085-0312-F06-L-STR | Length 12 mm | In distribution |
| X085-0108-F06-SP-STR | Depth 6 mm | In distribution |
| X085-0110-F04-STR | Depth 4 mm | In distribution |
| X085-0150-STR | In distribution | |
| X085-0212-F06 | Depth 6 mm | In distribution |
| X085-0250 | In distribution | |
| X085-0106-F06-SP-STR | Length 6 mm | In distribution |
| X085-0110-U-STR | Length 10 mm | In distribution |
| X085-0312-F04-R-STR | Depth 4 mm | In distribution |
| X085-0250-STR | In distribution | |
| X085-0310-H06-RU | Depth 6 mm | In distribution |
| X085-0312-H06-LU-STR | Length 12 mm | In distribution |
| X085-0106-F04-U-STR | Depth 6 mm | In distribution |
| X085-0310-F06-R | Depth 6 mm | In distribution |
| X085-0306-F06-R | Length 6 mm | In distribution |
| X085-0312-H06-L-STR | Length 12 mm | In distribution |
| X085-0106-H06-SP | Length 6 mm | In distribution |
| X085-0108-H04 | Length 8 mm | In distribution |
| X085-0210-F04 | Depth 4 mm | In distribution |
| X085-0308-F06-L | Length 8 mm | In distribution |
| X085-0206 | Length 6 mm | In distribution |
| X085-0108 | Length 8 mm | In distribution |
| X085-0110-F06-SP-STR | Depth 6 mm | In distribution |
| X085-0308-F06-L-STR | Length 8 mm | In distribution |
| X085-0208-H06-STR | Depth 6 mm | In distribution |
| X085-0306-H04-R | Length 6 mm | In distribution |
| X085-0308-H04-L | Length 8 mm | In distribution |
| X085-0106-STR | Length 6 mm | In distribution |
| X085-0112-F06-SP | Length 12 mm | In distribution |
| X085-0112-F04-SP-STR | Depth 4 mm | In distribution |
| X085-0108-H06-STR | Depth 6 mm | In distribution |
| X085-0308-H06-R | Depth 6 mm | In distribution |
| X085-0306-F04-L-STR | Depth 4 mm | In distribution |
| X085-2607-STR | Length 7 mm | In distribution |
| X085-0210-STR | Length 10 mm | In distribution |
| X085-0106-H06 | Length 6 mm | In distribution |
| X085-0108-F04 | Length 8 mm | In distribution |
| X085-0106-F06-SP | Length 6 mm | In distribution |
| X085-0310-H06-L-STR | Length 10 mm | In distribution |
| X085-0310-H06-RU-STR | Depth 6 mm | In distribution |
| X085-0110-H04-SP | Depth 4 mm | In distribution |
| X085-0308-H04-R-STR | Length 8 mm | In distribution |
| X085-0210-H06-STR | Length 10 mm | In distribution |
| X085-0312-H06-R | Length 12 mm | In distribution |
| X085-0112-H04-SP-STR | Depth 4 mm | In distribution |
| X085-0108-U | Length 8 mm | In distribution |
| X085-3006-STR | Outer Diameter 3 mm | In distribution |
| X085-0210-H06 | Length 10 mm | In distribution |
| X085-0108-U-STR | Length 8 mm | In distribution |
| X085-0112-H04-SP | Depth 4 mm | In distribution |
| X085-0108-H04-SP | Length 8 mm | In distribution |
| X085-2609-STR | Outer Diameter 2.6 mm | In distribution |
| X085-0208-F06-STR | Depth 6 mm | In distribution |
| X085-0306-H04-RU-STR | Length 6 mm | In distribution |
| X085-0112-F06-SP-STR | Length 12 mm | In distribution |
| X085-0308-F04-L | Length 8 mm | In distribution |
| X085-0308-H06-R-STR | Length 8 mm | In distribution |
| X085-0212-F04-STR | Depth 4 mm | In distribution |
| X085-0208-F04 | Length 8 mm | In distribution |
| X085-0310-H06-R-STR | Length 10 mm | In distribution |
| X085-0112-H06-SP-STR | Depth 6 mm | In distribution |
| X085-0112-SP | Length 12 mm | In distribution |
| X085-0106-H06-SP-STR | Depth 6 mm | In distribution |
| X085-0208-H06 | Depth 6 mm | In distribution |
| X085-0308-F06-R | Length 8 mm | In distribution |
| X085-0206-F06-STR | Length 6 mm | In distribution |
| X085-0206-H06-STR | Length 6 mm | In distribution |
| X085-3007-STR | Length 7 mm | In distribution |
| X085-0310-F04-L | Depth 4 mm | In distribution |
| X085-0108-H06 | Length 8 mm | In distribution |
| X085-0112-F04 | Length 12 mm | In distribution |
| X085-0106-F06 | Length 6 mm | In distribution |
| X085-0306-F06-R-STR | Depth 6 mm | In distribution |
| X085-0312-H06-RU-STR | Length 12 mm | In distribution |
| X085-0110-STR | Length 10 mm | In distribution |
| X085-0106-F04 | Length 6 mm | In distribution |
| X085-2608-STR | Length 8 mm | In distribution |
| X085-0312-H04-RU-STR | Depth 4 mm | In distribution |
| X085-0112-SP-STR | Length 12 mm | In distribution |
| X085-0308-F06-R-STR | Depth 6 mm | In distribution |
| X085-0108-F04-SP | Depth 4 mm | In distribution |
| X085-0112-H06 | Depth 6 mm | In distribution |
| X085-0106-H04 | Depth 4 mm | In distribution |
| X085-3008-STR | Length 8 mm | In distribution |
| X085-0310-F06-L | Length 10 mm | In distribution |
| X085-0106-H04-STR | Depth 4 mm | In distribution |
| X085-0208-F06 | Length 8 mm | In distribution |
| X085-0112-H04-STR | Length 12 mm | In distribution |
| X085-0110-U | Length 10 mm | In distribution |
| X085-0306-H06-LU | Length 6 mm | In distribution |
| X085-0206-H06 | Length 6 mm | In distribution |
| X085-3008 | Outer Diameter 3 mm | In distribution |
| X085-0212-F04 | Length 12 mm | In distribution |
| X085-0310-F04-R-STR | Depth 4 mm | In distribution |
| X085-0106-H04-SP | Depth 4 mm | In distribution |
| X085-0308-H04-L-STR | Length 8 mm | In distribution |
| X085-0106-F06-U-STR | Depth 6 mm | In distribution |
| X085-0210-F06 | Depth 6 mm | In distribution |
| X085-0108-SP-STR | Length 8 mm | In distribution |
Showing 250 of 265 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.