Pyramid® +4 Anterior Lumbar Plate System
Screw X0909045 PYR TI Canc Duld 6.5X27.5
14manufacturers in China registered for this device type
69catalogue numbers in this listing
20510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 510(k) | K080429 |
| Record published | 2015-08-18 |
| Record revised | 2025-11-20 (version 8) |
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 6.5 to 46 mm; length 3 to 100 mm |
| Distribution end date | 2026-01-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9874045 | Outer Diameter 45.0 mm | In distribution |
| 98716250 | Outer Diameter 6.5 mm | In distribution |
| 9874043 | In distribution | |
| 98716350 | Length 35.0 mm | In distribution |
| 98716250 | In distribution | |
| 9874035 | Outer Diameter 35.0 mm | In distribution |
| 9873137 | In distribution | |
| X1210060 | Outer Diameter 36.0 mm | In distribution |
| X1210074 | Length 25.0 mm | In distribution |
| 98716200 | In distribution | |
| 9873137 | Length 37.0 mm | In distribution |
| 9874041 | In distribution | |
| X1010598 | Outer Diameter 9.5 mm | In distribution |
| 9874045 | In distribution | |
| 9873135 | Length 35.0 mm | In distribution |
| 9873133 | Length 33.0 mm | In distribution |
| X1210076 | Length 30.0 mm | In distribution |
| X1210078 | Length 35.0 mm | In distribution |
| 9874043 | In distribution | |
| X0409001 | In distribution | |
| 9873135 | In distribution | |
| 9873133 | In distribution | |
| 9874039 | Outer Diameter 39.0 mm | In distribution |
| 9874037 | Outer Diameter 37.0 mm | In distribution |
| 9873141 | In distribution | |
| X1210062 | Outer Diameter 40.0 mm | In distribution |
| 98716200 | Outer Diameter 6.5 mm | In distribution |
| 9874041 | In distribution | |
| 98716300 | Length 30.0 mm | In distribution |
| 9873139 | In distribution | |
| 9874037 | In distribution | |
| X1210061 | Outer Diameter 38.0 mm | In distribution |
| 9873141 | Length 41.0 mm | In distribution |
| 9873139 | Length 39.0 mm | In distribution |
| 98716300 | In distribution | |
| 9874039 | In distribution | |
| 98716350 | In distribution | |
| 9874035 | In distribution | |
| 9873041 | Outer Diameter 41.0 mm | Withdrawn |
| X1210067 | Outer Diameter 42.0 mm | Withdrawn |
| X1210066 | Outer Diameter 40.0 mm | Withdrawn |
| X0909045 | Length 27.5 mm | Withdrawn |
| X1210089 | Outer Diameter 7.0 mm | Withdrawn |
| X1210069 | Outer Diameter 46.0 mm | Withdrawn |
| X1210075 | Outer Diameter 6.5 mm | Withdrawn |
| X1210073 | Length 22.5 mm | Withdrawn |
| 9873037 | Outer Diameter 37.0 mm | Withdrawn |
| 9873033 | Outer Diameter 33.0 mm | Withdrawn |
| X1210063 | Outer Diameter 42.0 mm | Withdrawn |
| X1210077 | Outer Diameter 6.5 mm | Withdrawn |
| X1210065 | Outer Diameter 38.0 mm | Withdrawn |
| X1210064 | Outer Diameter 36.0 mm | Withdrawn |
| X1210085 | Length 25.0 mm | Withdrawn |
| X0909043 | Outer Diameter 6.5 mm | Withdrawn |
| X0909042 | Outer Diameter 6.5 mm | Withdrawn |
| X1210088 | Outer Diameter 7.0 mm | Withdrawn |
| X1210087 | Length 3.0 mm | Withdrawn |
| X1210083 | Outer Diameter 7.0 mm | Withdrawn |
| X0909044 | Outer Diameter 6.5 mm | Withdrawn |
| X0909047 | Outer Diameter 6.5 mm | Withdrawn |
| X1210086 | Outer Diameter 7.0 mm | Withdrawn |
| X1210059 | Outer Diameter 34.0 mm | Withdrawn |
| X0909046 | Length 30.0 mm | Withdrawn |
| 9873035 | Outer Diameter 35.0 mm | Withdrawn |
| X1210084 | Length 22.5 mm | Withdrawn |
| X0909048 | Length 35.0 mm | Withdrawn |
| X1210072 | Length 20.0 mm | Withdrawn |
| 9873039 | Outer Diameter 39.0 mm | Withdrawn |
| X1210068 | Outer Diameter 44.0 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140417 | 2014-07-09 |
| K081038 | 2008-08-15 |
| K063100 | 2007-02-23 |
| K061274 | 2006-05-25 |
| K050117 | 2005-02-17 |
| K043151 | 2005-02-01 |
| K031782 | 2005-02-01 |
| K042922 | 2004-11-19 |
| K042499 | 2004-10-07 |
| K042235 | 2004-09-17 |
| K042025 | 2004-08-25 |
| K041217 | 2004-05-28 |
| K040962 | 2004-05-14 |
| K032265 | 2003-08-11 |
| K030327 | 2003-02-26 |
| K021761 | 2002-09-17 |
| K021461 | 2002-07-22 |
| K021226 | 2002-05-13 |
| K013665 | 2002-01-29 |
| K994239 | 2000-06-19 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2011-11-30 | Not classified | Mixed-up of materials/components | One screw may be longer then size etched on the screw. | 252 units | 2012-04-05 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2011-11-30 | Not classified | Mixed-up of materials/components | One screw may be longer then size etched on the screw. | 30 units | 2012-04-05 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2011-06-28 | Not classified | Other | Screws are longer then size etched on the screw. | 199 units | 2012-12-24 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2011-06-28 | Not classified | Other | Screws are longer then size etched on the screw. | 101 units | 2012-12-24 |
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.