Tsrh® Spinal System
Screw 83545209 Tsrh OG Thin 4.5MM X 20MM
11manufacturers in China registered for this device type
480catalogue numbers in this listing
44510(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 | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| 510(k) | K041282 |
| Record published | 2015-07-30 |
| Record revised | 2024-12-24 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 1.625 to 540 mm; outer diameter 4.5 to 12 mm; length 0.375 to 21.25 in; length 29 to 51 cm; width 5.5 to 8.5 mm |
| Distribution end date | 2025-12-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 824-005 | In distribution | |
| X0807095 | Outer Diameter 5.5 mm | In distribution |
| 83545209 | In distribution | |
| 83555309 | In distribution | |
| 83555551 | Outer Diameter 5.5 mm | In distribution |
| 824-010 | Length 0.375 in | In distribution |
| 8370090 | In distribution | |
| 8372550 | Width 5.5 mm | In distribution |
| 828-796 | Outer Diameter 5.5 mm | In distribution |
| 8377540 | In distribution | |
| X1102402 | Outer Diameter 6.35 mm | In distribution |
| 810-406 | Length 1.25 in | In distribution |
| 828-101 | In distribution | |
| 830-051 | Length 51.0 cm | In distribution |
| 811-307 | Length 1.375 in | In distribution |
| 8371760 | Length 60.0 mm | In distribution |
| 837-135 | Outer Diameter 6.35 mm | In distribution |
| X1102002 | 0.513″ | In distribution |
| 811-321 | Length 1.55 in | In distribution |
| 810-305 | Length 1.125 in | In distribution |
| 811-405 | Length 1.125 in | In distribution |
| X0209482 | Outer Diameter 7.0 mm | In distribution |
| 8379124 | In distribution | |
| 88947530 | Length 30.0 mm | In distribution |
| 88900102 | In distribution | |
| X11031145 | Outer Diameter 11.0 mm | In distribution |
| X0209463 | Outer Diameter 6.0 mm | In distribution |
| 837-545 | Outer Diameter 5.5 mm | In distribution |
| X8301531 | Length 31.0 cm | In distribution |
| X0310525 | Length 45.0 mm | In distribution |
| 88944535 | Outer Diameter 4.5 mm | In distribution |
| X1102005 | 0.513″ | In distribution |
| X0210175 | Length 55.0 mm | In distribution |
| 810-301 | Length 0.625 in | In distribution |
| 830-551 | Length 21.25 in | In distribution |
| 824-007 | In distribution | |
| 828-196C | 3/16″ (4.76mm) | In distribution |
| 83575259H | Length 25.0 mm | In distribution |
| 808-080 | Length 20.0 in | In distribution |
| 83555401 | Outer Diameter 5.5 mm | In distribution |
| 83565409 | In distribution | |
| 808-087 | Length 20.0 in | In distribution |
| 88945025 | Outer Diameter 5.0 mm | In distribution |
| 83575351 | Outer Diameter 7.5 mm | In distribution |
| 811-305 | Length 1.125 in | In distribution |
| 83575559H | Length 55.0 mm | In distribution |
| 811-407 | Length 1.375 in | In distribution |
| X1003945 | Outer Diameter 9.0 mm | In distribution |
| 808-840 | Outer Diameter 6.5 mm | In distribution |
| 830-035 | Length 35.0 cm | In distribution |
| 828-111 | In distribution | |
| 808-190 | In distribution | |
| 828-825 | Length 25.0 mm | In distribution |
| 8376735 | In distribution | |
| 83585459 | In distribution | |
| 83565201 | Length 20.0 mm | In distribution |
| 855011L70 | Length 70.0 mm | In distribution |
| 811-306 | Length 1.25 in | In distribution |
| X10031235 | Outer Diameter 12.0 mm | In distribution |
| X1102404 | Outer Diameter 6.35 mm | In distribution |
| 810-400 | Length 0.375 in | In distribution |
| 830-033 | 1/4 Inch | In distribution |
| X0607031 | Length 45.0 mm | In distribution |
| 828-083 | 1/4 Inch | In distribution |
| X0807090 | Length 35.0 mm | In distribution |
| 828-940 | Outer Diameter 7.5 mm | In distribution |
| 837-550 | Outer Diameter 5.5 mm | In distribution |
| X0792-010 | Outer Diameter 5.5 mm | In distribution |
| X0103411 | Length 1.875 mm | In distribution |
| 837-450 | Length 50.0 mm | In distribution |
| 828-116 | In distribution | |
| 88936540 | Outer Diameter 6.5 mm | In distribution |
| 1556001115 | Length 115.0 mm | In distribution |
| 88925050 | Length 50.0 mm | In distribution |
| 811-406 | Length 1.25 in | In distribution |
| 828-955 | Length 55.0 mm | In distribution |
| X0209446 | Outer Diameter 5.0 mm | In distribution |
| 83555609H | Length 60.0 mm | In distribution |
| X0795-770 | Outer Diameter 7.0 mm | In distribution |
| X1002600 | 0.651″ | In distribution |
| 810-403 | Length 0.875 in | In distribution |
| 828-104 | In distribution | |
| 828-790 | Length 40.0 mm | In distribution |
| X1102401 | Outer Diameter 6.35 mm | In distribution |
| 88900208 | In distribution | |
| 83575501 | Outer Diameter 7.5 mm | In distribution |
| 88925030 | Length 30.0 mm | In distribution |
| 83585359H | Outer Diameter 8.5 mm | In distribution |
| 830-045 | 1/4 Inch | In distribution |
| 810-302 | Length 0.75 in | In distribution |
| X0210171 | Length 35.0 mm | In distribution |
| 855011L55 | Length 55.0 mm | In distribution |
| 8371545 | Outer Diameter 5.5 mm | In distribution |
| X1102405 | Outer Diameter 6.35 mm | In distribution |
| 810-402 | Length 0.75 in | In distribution |
| 8379120 | In distribution | |
| 83545251 | Outer Diameter 4.5 mm | In distribution |
| 88944525 | Length 25.0 mm | In distribution |
| X0209449 | Outer Diameter 5.0 mm | In distribution |
| 88944550 | Outer Diameter 4.5 mm | In distribution |
| X0311205 | Outer Diameter 5.5 mm | In distribution |
| 8371060 | Length 60.0 mm | In distribution |
| 83575408 | In distribution | |
| 1556001035 | In distribution | |
| 8372760 | Width 7.5 mm | In distribution |
| X0310446 | Length 60.0 mm | In distribution |
| X0103410 | Outer Diameter 6.35 mm | In distribution |
| X828-245 | Length 45.0 mm | In distribution |
| 83555451 | Length 45.0 mm | In distribution |
| 83575357 | In distribution | |
| 8377730 | In distribution | |
| 828-090 | Length 508.0 mm | In distribution |
| 828-850 | Length 50.0 mm | In distribution |
| X0210184 | Length 30.0 mm | In distribution |
| 810-408 | Length 1.5 in | In distribution |
| 8370055 | In distribution | |
| 810-404 | Length 1.0 in | In distribution |
| X0209488 | Length 55.0 mm | In distribution |
| 810-451 | In distribution | |
| 824-040 | Length 0.875 in | In distribution |
| X0209457 | Length 35.0 mm | In distribution |
| 83565307 | In distribution | |
| 1556001070 | Length 70.0 mm | In distribution |
| 8372830 | Width 8.5 mm | In distribution |
| 824-000 | Length 0.625 in | In distribution |
| 855011L75 | Length 75.0 mm | In distribution |
| X1206123 | In distribution | |
| 83585309 | In distribution | |
| 83555309H | Length 30.0 mm | In distribution |
| 83575251 | Length 25.0 mm | In distribution |
| 837-125 | Length 5.5 mm | In distribution |
| 8372545 | Width 5.5 mm | In distribution |
| X1003935 | Outer Diameter 9.0 mm | In distribution |
| X0209490 | Length 20.0 mm | In distribution |
| X1002300 | 0.651″ | In distribution |
| 830-541 | Length 41.0 cm | In distribution |
| 830-550 | Outer Diameter 5.5 mm | In distribution |
| 810-307 | Length 1.375 in | In distribution |
| 811-302 | Length 0.75 in | In distribution |
| 811-403 | Length 0.875 in | In distribution |
| 810-200 | Length 0.375 in | In distribution |
| X0807109 | Outer Diameter 7.5 mm | In distribution |
| 830-537 | Length 37.0 cm | In distribution |
| 811-404 | Length 1.0 in | In distribution |
| 8377645 | In distribution | |
| 88936550 | Length 50.0 mm | In distribution |
| 828-118 | In distribution | |
| 810-405 | Length 1.125 in | In distribution |
| 8371745 | Length 45.0 mm | In distribution |
| 824-206 | In distribution | |
| 83555607 | In distribution | |
| 88900108 | In distribution | |
| 824-027 | Length 1.25 in | In distribution |
| 88946560 | Outer Diameter 6.5 mm | In distribution |
| 808-195C | In distribution | |
| 8371540 | Outer Diameter 5.5 mm | In distribution |
| X0795-880 | Outer Diameter 8.0 mm | In distribution |
| 808-193C | In distribution | |
| 8371050 | Length 50.0 mm | In distribution |
| 83565407 | In distribution | |
| 83585459 | In distribution | |
| 88948590 | Length 90.0 mm | In distribution |
| 83565557 | In distribution | |
| X0608093 | Length 65.0 mm | In distribution |
| 83585409 | In distribution | |
| X1102009 | 0.651″ | In distribution |
| X0103860 | Length 60.0 mm | In distribution |
| 830-535 | Outer Diameter 5.5 mm | In distribution |
| 811-323 | Length 2.15 in | In distribution |
| 828-830 | Outer Diameter 6.5 mm | In distribution |
| 810-303 | Length 0.875 in | In distribution |
| 830-531 | Outer Diameter 5.5 mm | In distribution |
| 828-840 | Outer Diameter 6.5 mm | In distribution |
| X0103855 | Outer Diameter 8.5 mm | In distribution |
| 83585301 | Length 30.0 mm | In distribution |
| 88934525 | Outer Diameter 4.5 mm | In distribution |
| X1194-609 | 9mm | In distribution |
| 808-083 | 1/4 Inch | In distribution |
| X1103135 | Outer Diameter 10.0 mm | In distribution |
| 8377650 | In distribution | |
| 811-408 | Length 1.5 in | In distribution |
| 837-455 | Outer Diameter 7.5 mm | In distribution |
| X1002500 | 0.651″ | In distribution |
| 828-795 | Length 45.0 mm | In distribution |
| 855011L95 | Length 95.0 mm | In distribution |
| X0607099 | In distribution | |
| 808-194C | In distribution | |
| 88936545 | Length 45.0 mm | In distribution |
| 828-780 | Outer Diameter 5.5 mm | In distribution |
| 830-539 | Length 39.0 cm | In distribution |
| 83565357 | In distribution | |
| 811-303 | Length 0.875 in | In distribution |
| 808-145 | In distribution | |
| X0210177 | Length 30.0 mm | In distribution |
| X1002400 | 0.651″ | In distribution |
| 811-322 | Length 1.75 in | In distribution |
| 8372655 | Width 6.5 mm | In distribution |
| 828-785 | Outer Diameter 5.5 mm | In distribution |
| 8371535 | Outer Diameter 5.5 mm | In distribution |
| 83565509 | In distribution | |
| X0209485 | Length 40.0 mm | In distribution |
| 1556001045 | Length 45.0 mm | In distribution |
| 828-835 | Length 35.0 mm | In distribution |
| 824-028 | Length 1.75 in | In distribution |
| 1556001045 | In distribution | |
| 828-855 | Length 55.0 mm | In distribution |
| 88944530 | Length 30.0 mm | In distribution |
| X0792-013 | Outer Diameter 5.5 mm | In distribution |
| 8371655 | Outer Diameter 6.5 mm | In distribution |
| 808-780 | Length 30.0 mm | In distribution |
| 83565259H | Length 25.0 mm | In distribution |
| 828-950 | Outer Diameter 7.5 mm | In distribution |
| 83575551 | Length 55.0 mm | In distribution |
| X828-250 | Outer Diameter 5.5 mm | In distribution |
| 811-402 | Length 0.75 in | In distribution |
| 830-039 | Length 39.0 cm | In distribution |
| 88900113 | In distribution | |
| 810-407 | Length 1.375 in | In distribution |
| 828-945 | Outer Diameter 7.5 mm | In distribution |
| X1102004 | 0.513″ | In distribution |
| X0210192 | Length 35.0 mm | In distribution |
| X0592-007 | Outer Diameter 6.5 mm | In distribution |
| 88947540 | Outer Diameter 7.5 mm | In distribution |
| X0607100 | In distribution | |
| 824-030 | Length 2.75 in | In distribution |
| X0608089 | Length 45.0 mm | In distribution |
| 83545509H | Outer Diameter 4.5 mm | In distribution |
| 83555409H | Outer Diameter 5.5 mm | In distribution |
| 1556001060 | In distribution | |
| 1556001035 | Length 35.0 mm | In distribution |
| 828-935 | Outer Diameter 7.5 mm | In distribution |
| 824-029 | Length 2.25 in | In distribution |
| 8379120C | In distribution | |
| 808-785 | Outer Diameter 5.5 mm | In distribution |
| X0807132 | In distribution | |
| 83575358 | In distribution | |
| 808-086 | Outer Diameter 7.0 mm | In distribution |
| 830-037 | 1/4 Inch | In distribution |
| 83545409H | Length 40.0 mm | In distribution |
| 824-001 | Length 0.75 in | In distribution |
| 83575559 | In distribution | |
| 88936555 | Outer Diameter 6.5 mm | In distribution |
| 83555358 | In distribution | |
| 88927530 | Outer Diameter 7.5 mm | In distribution |
| 830-031 | Length 31.0 cm | In distribution |
| 8371640 | Length 40.0 mm | In distribution |
| X1102007 | 0.651″ | In distribution |
| 8377755 | In distribution | |
| X0210172 | Length 40.0 mm | In distribution |
| 83555259H | Length 25.0 mm | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
|---|---|
| K121191 | 2012-06-29 |
| K102886 | 2011-01-26 |
| K090714 | 2009-04-17 |
| K083071 | 2008-11-14 |
| K081297 | 2008-06-11 |
| K080805 | 2008-04-18 |
| K071942 | 2007-12-11 |
| K062447 | 2007-10-15 |
| K070742 | 2007-09-14 |
| K061591 | 2006-09-08 |
| K061579 | 2006-08-11 |
| K060081 | 2006-02-13 |
| K052734 | 2005-10-21 |
| K052376 | 2005-09-23 |
| K052402 | 2005-09-23 |
| K052180 | 2005-08-23 |
| K050484 | 2005-05-04 |
| K043053 | 2005-04-11 |
| K043020 | 2005-01-07 |
| K042789 | 2004-12-21 |
| K042524 | 2004-10-08 |
| K042498 | 2004-10-07 |
| K042402 | 2004-10-01 |
| K041862 | 2004-09-15 |
| K041282 | 2004-06-10 |
| K030875 | 2003-06-24 |
| K031533 | 2003-06-13 |
| K030816 | 2003-06-06 |
| K023415 | 2002-12-13 |
| K023797 | 2002-12-13 |
| K014296 | 2002-12-10 |
| K023555 | 2002-11-22 |
| K022191 | 2002-08-28 |
| K021061 | 2002-07-25 |
| K022070 | 2002-07-22 |
| K022015 | 2002-07-18 |
| K020709 | 2002-05-09 |
| K020426 | 2002-02-26 |
| K020155 | 2002-02-05 |
| K014267 | 2002-01-25 |
| K003780 | 2001-09-28 |
| K011508 | 2001-06-12 |
| K010181 | 2001-06-12 |
| K001532 | 2000-06-16 |
Recalls Naming This Product
10 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. | 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 |
| Warsaw Orthopedic, Inc. | 510(k) number | 2008-10-31 | Not classified | Process control | The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation. | 43 sets | 2009-11-18 |
| Warsaw Orthopedic, Inc. | 510(k) number | 2008-10-31 | Not classified | Process control | The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation. | 3,545 | 2009-11-18 |
| Warsaw Orthopedic, Inc. | 510(k) number | 2008-10-31 | Not classified | Process control | The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation. | 446 | 2009-11-18 |
| Warsaw Orthopedic, Inc. | 510(k) number | 2008-10-31 | Not classified | Process control | The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation. | 119 | 2009-11-18 |
| 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.