ES2 Spinal System
40 catalogue numbers from 482806120, listed by Stryker GmbH, Switzerland, under Appliance, Fixation, Spinal Interlaminal. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
40catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2014-12-08 |
| Record revised | 2024-09-11 (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, manufacturing date |
| Sizes | Length 30 to 480 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 482806120 | Length 120.0 mm | In distribution |
| 482802870 | Length 70.0 mm | In distribution |
| 482802860 | Length 60.0 mm | In distribution |
| 482805110 | Diameter: 6.0 Millimeter | In distribution |
| 482808065 | Length 65.0 mm | In distribution |
| 482808050 | Diameter: 5.5 Millimeter | In distribution |
| 482804535 | Diameter: 5.5 Millimeter | In distribution |
| 482802790 | Diameter: 7.5 Millimeter | In distribution |
| 482806030 | Length 30.0 mm | In distribution |
| 482802660 | Length 60.0 mm | In distribution |
| 48280084 | In distribution | |
| 482807040 | Diameter: 5.5 Millimeter | In distribution |
| 482805060 | Diameter: 6.0 Millimeter | In distribution |
| 482805055 | Diameter: 6.0 Millimeter | In distribution |
| 482802630 | Diameter: 6.5 Millimeter | In distribution |
| 482806055 | Length 55.0 mm | In distribution |
| 482806100 | Length 100.0 mm | In distribution |
| 482804790 | Diameter: 7.5 Millimeter | In distribution |
| 482808160 | Length 160.0 mm | In distribution |
| 482807170 | Diameter: 5.5 Millimeter | In distribution |
| 482808180 | Length 180.0 mm | In distribution |
| 482807100 | Diameter: 5.5 Millimeter | In distribution |
| 482802550 | Diameter: 5.5 Millimeter | In distribution |
| 482808140 | Length 140.0 mm | In distribution |
| 482806075 | Diameter: 5.5 Millimeter | In distribution |
| 482804845 | Diameter: 8.5 Millimeter | In distribution |
| 482805120 | Length 120.0 mm | In distribution |
| 482802530 | Length 30.0 mm | In distribution |
| 482805140 | Length 140.0 mm | In distribution |
| 482802735 | Length 35.0 mm | In distribution |
| 482804650 | Length 50.0 mm | In distribution |
| 482802645 | Diameter: 6.5 Millimeter | In distribution |
| 482804735 | Diameter: 7.5 Millimeter | In distribution |
| 482802740 | Length 40.0 mm | In distribution |
| 482808480 | Length 480.0 mm | In distribution |
| 482808110 | Length 110.0 mm | In distribution |
| 482808055 | Diameter: 5.5 Millimeter | In distribution |
| 482802445 | Diameter: 4.5 Millimeter | In distribution |
| 482802840 | Length 40.0 mm | In distribution |
| 482802890 | Length 90.0 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150753 | 2015-06-09 |
| K142741 | 2015-01-15 |
| K930009 | 1994-09-01 |
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.