Thor
TWO Level Sacral Compression Plate
14manufacturers in China registered for this device type
61catalogue numbers in this listing
7510(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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K080773 |
| Record published | 2015-09-14 |
| 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, manufacturing date |
| Sizes | Length 22 to 100 mm |
| Distribution end date | 2025-03-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 48032048 | Length 48.0 mm | Withdrawn |
| 480316549 | Diameter: 6.5 Millimeter | Withdrawn |
| 480316046 | Length 46.0 mm | Withdrawn |
| 480316528 | Diameter: 6.5 Millimeter | Withdrawn |
| 48030289 | Length 89.0 mm | Withdrawn |
| 48032064 | Length 64.0 mm | Withdrawn |
| 480316037 | Diameter: 6.0 Millimeter | Withdrawn |
| 48035350 | Diameter: 6.5 Millimeter | Withdrawn |
| 480316561 | Diameter: 6.5 Millimeter | Withdrawn |
| 480316031 | Length 31.0 mm | Withdrawn |
| 480316025 | Diameter: 6.0 Millimeter | Withdrawn |
| 480316525 | Diameter: 6.5 Millimeter | Withdrawn |
| 48032092 | Length 92.0 mm | Withdrawn |
| 480316540 | Diameter: 6.5 Millimeter | Withdrawn |
| 48030277 | Length 77.0 mm | Withdrawn |
| 48030283 | Length 83.0 mm | Withdrawn |
| 48030040 | Length 40.0 mm | Withdrawn |
| 48030025 | Length 25.0 mm | Withdrawn |
| 480316558 | Length 58.0 mm | Withdrawn |
| 480316552 | Length 52.0 mm | Withdrawn |
| 480316555 | Diameter: 6.5 Millimeter | Withdrawn |
| 48032096 | Length 96.0 mm | Withdrawn |
| 480316055 | Diameter: 6.0 Millimeter | Withdrawn |
| 48030031 | Length 31.0 mm | Withdrawn |
| 480316537 | Diameter: 6.5 Millimeter | Withdrawn |
| 480316567 | Length 67.0 mm | Withdrawn |
| 480316058 | Diameter: 6.0 Millimeter | Withdrawn |
| 480316049 | Diameter: 6.0 Millimeter | Withdrawn |
| 48032076 | Length 76.0 mm | Withdrawn |
| 480316052 | Length 52.0 mm | Withdrawn |
| 48032080 | Length 80.0 mm | Withdrawn |
| 480316543 | Diameter: 6.5 Millimeter | Withdrawn |
| 48032084 | Length 84.0 mm | Withdrawn |
| 48030037 | Length 37.0 mm | Withdrawn |
| 48032056 | Length 56.0 mm | Withdrawn |
| 480316043 | Diameter: 6.0 Millimeter | Withdrawn |
| 480316531 | Length 31.0 mm | Withdrawn |
| 480316534 | Length 34.0 mm | Withdrawn |
| 48030265 | Length 65.0 mm | Withdrawn |
| 480316546 | Length 46.0 mm | Withdrawn |
| 48032068 | Length 68.0 mm | Withdrawn |
| 48030271 | Length 71.0 mm | Withdrawn |
| 48030028 | Length 28.0 mm | Withdrawn |
| 48030022 | Length 22.0 mm | Withdrawn |
| 48030225 | Diameter: 6.0 Millimeter | Withdrawn |
| 48032088 | Length 88.0 mm | Withdrawn |
| 48030350 | Diameter: 6.0 Millimeter | Withdrawn |
| 480316564 | Diameter: 6.5 Millimeter | Withdrawn |
| 480316522 | Length 22.0 mm | Withdrawn |
| 48030034 | Length 34.0 mm | Withdrawn |
| 480316022 | Length 22.0 mm | Withdrawn |
| 48032044 | Length 44.0 mm | Withdrawn |
| 48032072 | Length 72.0 mm | Withdrawn |
| 48032060 | Length 60.0 mm | Withdrawn |
| 48035225 | Diameter: 6.5 Millimeter | Withdrawn |
| 48032052 | Length 52.0 mm | Withdrawn |
| 48032040 | Length 40.0 mm | Withdrawn |
| 480316040 | Length 40.0 mm | Withdrawn |
| 480316034 | Diameter: 6.0 Millimeter | Withdrawn |
| 48032100 | Length 100.0 mm | Withdrawn |
| 480316028 | Length 28.0 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 |
|---|---|
| K221728 | 2022-10-19 |
| K150700 | 2015-07-15 |
| K150449 | 2015-03-20 |
| K142237 | 2015-01-26 |
| K142699 | 2014-12-31 |
| K083020 | 2009-03-26 |
| K083562 | 2009-03-25 |
Recalls Naming This Product
31 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 |
|---|---|---|---|---|---|---|---|
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 1264 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 776 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 438 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 345 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 286 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 202 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 181 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 189 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 177 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 176 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 171 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 178 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 165 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 167 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 154 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 296 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 388 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 329 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 277 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 262 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 257 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 198 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 173 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 175 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 153 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 165 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 142 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 137 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 150 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 157 | 2013-01-23 |
| Stryker Spine | 510(k) number | 2009-10-02 | Not classified | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break a | 154 | 2013-01-23 |
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.