Pyramesh® C Titanium Mesh
Mesh 9050450 Pyramesh IMP 10MMX14MMX50MM
3manufacturers in China registered for this device type
66catalogue 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 | 2015-08-05 |
| Record revised | 2025-07-14 (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 | Length 17 to 90 mm; outer diameter 13 to 19 mm |
| Distribution end date | 2024-06-05 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9050713 | 13mm | In distribution | |
| 9051770 | In distribution | ||
| 905-800 | 25 | In distribution | |
| 9052890 | In distribution | ||
| 9051750 | 17mm x 22mm x 50mm | In distribution | |
| 905-133 | In distribution | ||
| 9051790 | 17mm x 22mm x 90mm | In distribution | |
| X050295 | 32mm x 11mm | In distribution | |
| XIB1101-009 | 9mm | In distribution | |
| XIB0203-004 | 7mm | In distribution | |
| 905-407 | In distribution | ||
| 9052270 | 22mm x 70mm ROUND | In distribution | |
| X0210021 | Outer Diameter 13.0 mm | In distribution | |
| 9050719 | In distribution | ||
| X1009460 | Length 17.0 mm | In distribution | |
| 9052250 | 22mm x 50mm ROUND | In distribution | |
| 9051730 | 17mm x 22mm x 30mm OVOID | In distribution | |
| 9051350 | 13mm x 50mm | In distribution | |
| 9052290 | In distribution | ||
| 9052890 | 22mm x 28mm x 90mm OVOID | In distribution | |
| 9052290 | 22mm x 90mm ROUND | In distribution | |
| 9051790 | 17mm x 22mm x 90mm OVOID | In distribution | |
| 905-199 | Length 90.0 mm | In distribution | |
| 905-137 | In distribution | ||
| 9051730 | In distribution | ||
| 9050713 | In distribution | ||
| X050291 | 32mm x 7mm | In distribution | |
| X050296 | 32mm x 12mm | In distribution | |
| 9051770 | 17mm x 22mm x 70mm OVOID | In distribution | |
| 9052270 | 22mm x 70mm | In distribution | |
| X050294 | 32mm x 10mm | In distribution | |
| X050284 | 25mm x 7mm | In distribution | |
| 9050722 | 22mm | In distribution | |
| XIB0801-005 | 8mm | In distribution | |
| 905-403 | In distribution | ||
| 9050450 | 10mm x 14mm x 50mm | In distribution | |
| 9051350 | In distribution | ||
| X050293 | 32mm x 9mm | In distribution | |
| 905-901 | In distribution | ||
| 9051750 | 17mm x 22mm x 50mm OVOID | In distribution | |
| 9050716 | 16mm | In distribution | |
| 9052870 | In distribution | ||
| 9050725 | In distribution | ||
| X1009461 | 13mm x 17mm x 50mm | In distribution | |
| XIB1101-035 | 19mm 15/12mm | In distribution | |
| X050285 | 25mm x 8mm | In distribution | |
| 9052250 | In distribution | ||
| 9052870 | 22mm x 28mm x 70mm OVOID | In distribution | |
| 9051690 | In distribution | ||
| 9050725 | 25mm | In distribution | |
| XIB1101-036 | 19mm 18/15mm | In distribution | |
| 9051690 | 16mm x 90mm ROUND | In distribution | |
| 9052850 | 22mm x 28mm x 50mm OVOID | In distribution | |
| 9050450 | 10mm x 14mm x 50mm | In distribution | |
| XIB0801-011 | 14mm | In distribution | |
| 9050719 | 19mm | In distribution | |
| X050292 | 32mm x 8mm | In distribution | |
| 905-800 | 25 | In distribution | |
| XIB0801-008 | 11mm | Withdrawn | |
| X0210022 | Outer Diameter 13.0 mm | Withdrawn | |
| X1009459 | 13mm x 17mm x 30mm | Withdrawn | |
| XIB0801-007 | 10mm | Withdrawn | |
| X0210024 | Length 17.0 mm | Withdrawn | |
| XIB0801-009 | 12mm | Withdrawn | |
| X0210023 | Length 17.0 mm | Withdrawn | |
| XIB0801-006 | 9mm | Withdrawn |
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.