Tsrh® Spinal System
Screw 83565459 Tsrh OG Thin 6.5MM X 45MM
14manufacturers in China registered for this device type
176catalogue 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) | K090740 |
| Record published | 2025-03-01 |
| Record revised | 2022-09-16 (version 9) |
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 6 to 540 mm; outer diameter 4.5 to 12 mm; length 0.375 to 20 in; width 5.5 to 7.5 mm; length 37 to 43 cm |
| Distribution end date | 2025-12-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 83565459 | In distribution | |
| 88947565 | Length 65.0 mm | In distribution |
| 88900205 | In distribution | |
| 837-335 | Outer Diameter 6.5 mm | In distribution |
| 8370100 | Outer Diameter 5.5 mm | In distribution |
| 816-015 | Length 15.0 mm | In distribution |
| 8372555 | Length 55.0 mm | In distribution |
| X1198-029 | Length 40.0 mm | In distribution |
| 8372635 | Width 6.5 mm | In distribution |
| X0807099 | Outer Diameter 6.5 mm | In distribution |
| 83565609 | In distribution | |
| X0210185 | Length 35.0 mm | In distribution |
| 855011L85 | Length 85.0 mm | In distribution |
| 8372730 | Length 30.0 mm | In distribution |
| 8370420 | Outer Diameter 4.5 mm | In distribution |
| 83585509 | In distribution | |
| X0210178 | Length 35.0 mm | In distribution |
| X0607051 | Length 39 to 45MM | In distribution |
| 88935525 | Length 25.0 mm | In distribution |
| X1194-606 | Length 6.0 mm | In distribution |
| 808-105 | In distribution | |
| 8372725 | Length 25.0 mm | In distribution |
| 8370435 | Outer Diameter 4.5 mm | In distribution |
| 88935545 | Outer Diameter 5.5 mm | In distribution |
| X0310444 | Length 40.0 mm | In distribution |
| 837-445 | Outer Diameter 7.5 mm | In distribution |
| 83575507 | In distribution | |
| 8372650 | Width 6.5 mm | In distribution |
| 88900211 | In distribution | |
| 88947545 | Outer Diameter 7.5 mm | In distribution |
| 83575209 | In distribution | |
| 83585359 | In distribution | |
| 88925055 | Length 55.0 mm | In distribution |
| X0608083 | Length 55.0 mm | In distribution |
| X0210179 | Length 40.0 mm | In distribution |
| X0807112 | Outer Diameter 7.5 mm | In distribution |
| 1556001055 | Length 55.0 mm | In distribution |
| 837-650 | Outer Diameter 6.5 mm | In distribution |
| X1198-028 | Length 35.0 mm | In distribution |
| 837-350 | Outer Diameter 6.5 mm | In distribution |
| 816-013 | Length 13.0 mm | In distribution |
| X0807093 | Length 50.0 mm | In distribution |
| 8370445 | Outer Diameter 4.5 mm | In distribution |
| X0210183 | Length 60.0 mm | In distribution |
| 8370070 | In distribution | |
| 8372540 | Length 40.0 mm | In distribution |
| 8379121 | In distribution | |
| X0310448 | Length 80.0 mm | In distribution |
| 88937560 | Outer Diameter 7.5 mm | In distribution |
| 816-017 | Length 17.0 mm | In distribution |
| 8372630 | Width 6.5 mm | In distribution |
| 855011L50 | Length 50.0 mm | In distribution |
| 88947590 | Outer Diameter 7.5 mm | In distribution |
| 83575359 | In distribution | |
| 88934520 | Length 20.0 mm | In distribution |
| 811-300 | Length 0.375 in | In distribution |
| 88945050 | Length 50.0 mm | In distribution |
| X8301537 | Outer Diameter 5.5 mm | In distribution |
| 83575459 | In distribution | |
| X8372035 | Outer Diameter 10.0 mm | In distribution |
| 88924545 | Length 45.0 mm | In distribution |
| 83545609 | In distribution | |
| X0807113 | Outer Diameter 7.5 mm | In distribution |
| 1556001050 | Length 50.0 mm | In distribution |
| 8370045 | Length 45.0 mm | In distribution |
| X1003950 | Outer Diameter 9.0 mm | In distribution |
| X0210180 | Length 45.0 mm | In distribution |
| X0807104 | Length 60.0 mm | In distribution |
| 88927540 | Length 40.0 mm | In distribution |
| X0210176 | Length 60.0 mm | In distribution |
| 8372530 | Outer Diameter 5.5 mm | In distribution |
| 88926555 | Outer Diameter 6.5 mm | In distribution |
| 83555359 | In distribution | |
| X1198-030 | Outer Diameter 8.5 mm | In distribution |
| 83585557 | In distribution | |
| X1194-706 | Length 6.0 mm | In distribution |
| 83545409 | In distribution | |
| X10031255 | Outer Diameter 12.0 mm | In distribution |
| X0608085 | Length 25.0 mm | In distribution |
| 83575309 | In distribution | |
| 808-088 | Length 20.0 in | In distribution |
| 8370045 | In distribution | |
| 88946545 | Length 45.0 mm | In distribution |
| 837-240 | Length 40.0 mm | In distribution |
| X0210181 | Length 50.0 mm | In distribution |
| 83575508 | In distribution | |
| 837-340 | Length 40.0 mm | In distribution |
| 83545459 | In distribution | |
| 837-330 | Outer Diameter 6.5 mm | In distribution |
| 83585507 | In distribution | |
| 83555559 | In distribution | |
| 88900110 | In distribution | |
| 837-540 | Length 40.0 mm | In distribution |
| 1556001100 | Length 100.0 mm | In distribution |
| 83575609 | In distribution | |
| 88926525 | Outer Diameter 6.5 mm | In distribution |
| 8370080 | In distribution | |
| 83555308 | In distribution | |
| X0807089 | Outer Diameter 5.5 mm | In distribution |
| 88900109 | In distribution | |
| 8370040 | Length 40.0 mm | In distribution |
| 88924525 | Length 25.0 mm | In distribution |
| 83555408 | In distribution | |
| 83585559 | In distribution | |
| X0795-990 | Length 90.0 mm | In distribution |
| X0210196 | Length 55.0 mm | In distribution |
| 88925025 | Length 25.0 mm | In distribution |
| 837-740 | Length 40.0 mm | In distribution |
| 88935530 | Length 30.0 mm | In distribution |
| 88945545 | Length 45.0 mm | In distribution |
| 8370050 | In distribution | |
| 8370100 | In distribution | |
| 837-460 | Length 60.0 mm | In distribution |
| 83555509 | In distribution | |
| 88935540 | Length 40.0 mm | In distribution |
| 88926530 | Outer Diameter 6.5 mm | In distribution |
| 88935550 | Outer Diameter 5.5 mm | In distribution |
| 8372520 | Length 20.0 mm | In distribution |
| 810-206 | Length 1.25 in | Withdrawn |
| 88947500 | Length 100.0 mm | Withdrawn |
| X1091-045 | Withdrawn | |
| 810-205 | Length 1.125 in | Withdrawn |
| 808-607 | Length 24.0 mm | Withdrawn |
| X187026540 | Length 40.0 mm | Withdrawn |
| 88945020 | Outer Diameter 5.0 mm | Withdrawn |
| 88926045 | Outer Diameter 6.0 mm | Withdrawn |
| 808-603 | Length 16.0 mm | Withdrawn |
| X0702850 | Outer Diameter 6.5 mm | Withdrawn |
| X0204855 | Length 55.0 mm | Withdrawn |
| X0410050 | Length 65.0 mm | Withdrawn |
| 88938560 | Outer Diameter 8.5 mm | Withdrawn |
| 88924555 | Outer Diameter 4.5 mm | Withdrawn |
| 808-610 | Length 30.0 mm | Withdrawn |
| 808-605 | Length 20.0 mm | Withdrawn |
| X09103827 | Length 55.0 mm | Withdrawn |
| X09103823 | Length 35.0 mm | Withdrawn |
| 88945560 | Outer Diameter 5.5 mm | Withdrawn |
| 88938555 | Outer Diameter 8.5 mm | Withdrawn |
| 88948555 | Length 55.0 mm | Withdrawn |
| 810-203 | Length 0.875 in | Withdrawn |
| 88926040 | Outer Diameter 6.0 mm | Withdrawn |
| X187025540 | Length 40.0 mm | Withdrawn |
| 808-604 | Length 18.0 mm | Withdrawn |
| X8301543 | Outer Diameter 5.5 mm | Withdrawn |
| 808-117 | Withdrawn | |
| 88936055 | Length 55.0 mm | Withdrawn |
| X0607081 | Length 55.0 mm | Withdrawn |
| 88925020 | Outer Diameter 5.0 mm | Withdrawn |
| 808-606 | Length 22.0 mm | Withdrawn |
| 88935045 | Length 45.0 mm | Withdrawn |
| 88934540 | Outer Diameter 4.5 mm | Withdrawn |
| 804-011 | Withdrawn | |
| 804-043 | Length 0.375 in | Withdrawn |
| X09103832 | Length 45.0 mm | Withdrawn |
| 88936565 | Outer Diameter 6.5 mm | Withdrawn |
| 837-250 | Outer Diameter 5.5 mm | Withdrawn |
| 808-116 | Withdrawn | |
| 88935030 | Length 30.0 mm | Withdrawn |
| 88928555 | Outer Diameter 8.5 mm | Withdrawn |
| X0410054 | Length 65.0 mm | Withdrawn |
| X0702845 | Length 45.0 mm | Withdrawn |
| 88938525 | Length 25.0 mm | Withdrawn |
| 88935025 | Outer Diameter 5.0 mm | Withdrawn |
| 810-201 | Length 0.625 in | Withdrawn |
| X0198-003 | Length 540.0 mm | Withdrawn |
| 8373745 | Withdrawn | |
| 808-609 | Length 28.0 mm | Withdrawn |
| X0204845 | Length 45.0 mm | Withdrawn |
| X0607082 | Length 50.0 mm | Withdrawn |
| 88934550 | Outer Diameter 4.5 mm | Withdrawn |
| X0198-004 | Outer Diameter 5.5 mm | Withdrawn |
| X0310540 | Length 45.0 mm | Withdrawn |
| X187026550 | Length 50.0 mm | Withdrawn |
| 808-608 | Length 26.0 mm | Withdrawn |
| 88927565 | Outer Diameter 7.5 mm | Withdrawn |
| X0702940 | Outer Diameter 7.5 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
7 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 | 2011-07-12 | Not classified | Error in labeling | Screws are 5 mm longer than the size etched on the screw. | 17 units | 2012-07-20 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2011-06-28 | Not classified | Other | Screws are longer then size etched on the screw. | 36 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. | 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 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2007-08-24 | Not classified | Device Design | Disassembly: The movable cradle component could detach from the saddle under extreme manipulation of the associated rods prior to final tightening of the set screws. | 20 units | 2009-08-21 |
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.