Pyramesh® Implant System
Mesh 9052215 Pyramesh Implt 22MMX15MM RD
3manufacturers in China registered for this device type
50catalogue numbers in this listing
30510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 510(k) | K011406 |
| Record published | 2025-07-10 |
| Record revised | 2022-08-02 (version 6) |
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 |
| Sizes | Outer diameter 13 to 25 mm; length 30 to 100 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9052850 | In distribution | |
| 905-112 | In distribution | |
| 905-401 | In distribution | |
| 905-256 | Outer Diameter 25.0 mm | In distribution |
| 905-612 | In distribution | |
| 905-312 | In distribution | |
| 905-311 | In distribution | |
| 9051918 | In distribution | |
| 9052215 | 22mm x 15mm | In distribution |
| 905-509 | In distribution | |
| 905-251 | In distribution | |
| 905-194 | Length 40.0 mm | In distribution |
| 9050514 | In distribution | |
| 9052315 | In distribution | |
| 9051014 | In distribution | |
| 905-512 | In distribution | |
| 905-399 | In distribution | |
| 905-115 | In distribution | |
| 905-194 | In distribution | |
| 905-163 | Length 30.0 mm | In distribution |
| 905-163 | In distribution | |
| 9050016 | In distribution | |
| 905-412 | In distribution | |
| 905-399 | 25mm | In distribution |
| 905-407 | 10mm x 14mm, L=70mm | In distribution |
| X0205111 | 10mm x 22mm x 10mm | In distribution |
| 905-411 | In distribution | |
| 905-133 | Outer Diameter 13.0 mm | In distribution |
| 9051314 | In distribution | |
| 905-299 | 19mm | In distribution |
| 9052518 | In distribution | |
| 905-256 | In distribution | |
| 9050414 | In distribution | |
| 9051715 | In distribution | |
| 905-166 | Length 60.0 mm | In distribution |
| 905-408 | In distribution | |
| 905-199 | Length 90.0 mm | In distribution |
| 905-609 | In distribution | |
| 905-255 | In distribution | |
| 905-166 | In distribution | |
| 9051050 | In distribution | |
| 905-403 | 10mm x 14mm, L=30mm | In distribution |
| 905-904 | In distribution | |
| 905-137 | Length 70.0 mm | In distribution |
| 9052318 | In distribution | |
| 905-611 | In distribution | |
| 9051315 | In distribution | |
| 905-103 | In distribution | |
| 905-251 | Outer Diameter 25.0 mm | In distribution |
| 905-139 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoRoent | Nuvasive, Inc. | 1,514 |
| Capri™ Corpectomy Cage System | VB Spine LLC | 1,509 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,189 |
| Fortify | Globus Medical, Inc. | 866 |
| Matrixx System | Nexxt Spine LLC | 748 |
| Ascend | Alphatec Spine, Inc. | 555 |
| Zavation VBR Trial | Zavation | 548 |
| Verte-Stack® Spinal System | Medtronic Sofamor Danek, Inc. | 484 |
| Timberline® Lateral Interbody Fusion System | Biomet Spine | 470 |
| Timberline Lateral Fusion System | Biomet Spine | 459 |
| Novel | Alphatec Spine, Inc. | 447 |
| Hawkeye™ Vertebral Body Replacement (VBR) | Choice Spine, LP | 368 |
Showing 12 of 683. All products under Spinal Vertebral Body Replacement Device
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173125 | 2017-12-20 |
| K131888 | 2013-09-23 |
| K082112 | 2008-08-27 |
| K071033 | 2007-08-14 |
| K070173 | 2007-03-14 |
| K063491 | 2007-03-05 |
| K062427 | 2006-09-12 |
| K062073 | 2006-08-14 |
| K061938 | 2006-08-09 |
| K060719 | 2006-04-14 |
| K052931 | 2005-11-16 |
| K051105 | 2005-06-09 |
| K043566 | 2005-01-07 |
| K043561 | 2004-12-29 |
| K041197 | 2004-08-09 |
| K033926 | 2004-07-07 |
| K041556 | 2004-07-01 |
| K041452 | 2004-06-24 |
| K040536 | 2004-05-05 |
| K040422 | 2004-03-19 |
| K040167 | 2004-02-18 |
| K031780 | 2003-07-30 |
| K030735 | 2003-04-18 |
| K030736 | 2003-04-02 |
| K030601 | 2003-03-25 |
| K024049 | 2003-02-26 |
| K023570 | 2002-11-19 |
| K021791 | 2002-08-26 |
| K011406 | 2001-12-27 |
| K010930 | 2001-10-24 |
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.