Tsrh® Spinal System
SCR X0209515 TSR3 21PS OG TI Hact 8.5X55
15manufacturers in China registered for this device type
236catalogue numbers in this listing
50510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K052144 |
| Record published | 2015-09-10 |
| Record revised | 2024-10-24 (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 12 to 540 mm; outer diameter 4.5 to 8.5 mm; length 41 cm |
| Distribution end date | 2024-12-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X0607033 | Length 55.0 mm | In distribution |
| 83565358 | In distribution | |
| 83575209H | Outer Diameter 7.5 mm | In distribution |
| 88926560 | Length 60.0 mm | In distribution |
| 83585506 | In distribution | |
| X0209515 | Outer Diameter 8.5 mm | In distribution |
| 83585451 | Length 45.0 mm | In distribution |
| 83545501 | Length 50.0 mm | In distribution |
| 83585259H | Length 25.0 mm | In distribution |
| 83575458 | In distribution | |
| 83575506 | In distribution | |
| 88924530 | Length 30.0 mm | In distribution |
| 83585556 | In distribution | |
| 83575356 | In distribution | |
| 1556001085 | Length 85.0 mm | In distribution |
| 83555406 | In distribution | |
| 1556001110 | Length 110.0 mm | In distribution |
| 83585509H | Length 50.0 mm | In distribution |
| X0209452 | Length 55.0 mm | In distribution |
| 1556001100 | In distribution | |
| 83565209 | In distribution | |
| 83585407 | In distribution | |
| 83565456 | In distribution | |
| 83575556 | In distribution | |
| 8352500 | In distribution | |
| 83575401 | Outer Diameter 7.5 mm | In distribution |
| 83545556 | In distribution | |
| 83555506 | In distribution | |
| 88900107 | In distribution | |
| X0209467 | Length 40.0 mm | In distribution |
| 83565609 | In distribution | |
| 83545551 | Length 55.0 mm | In distribution |
| X0210187 | Length 45.0 mm | In distribution |
| 83585259 | In distribution | |
| 88935040 | Outer Diameter 5.0 mm | In distribution |
| 83555507 | In distribution | |
| 83575406 | In distribution | |
| 83545406 | In distribution | |
| X0209438 | Outer Diameter 4.5 mm | In distribution |
| 88946550 | Outer Diameter 6.5 mm | In distribution |
| 88937550 | Length 50.0 mm | In distribution |
| 88947580 | Length 80.0 mm | In distribution |
| 83565309H | Outer Diameter 6.5 mm | In distribution |
| 83585401 | Length 40.0 mm | In distribution |
| X0209462 | Length 60.0 mm | In distribution |
| 83545601 | Length 60.0 mm | In distribution |
| 83545359H | Length 35.0 mm | In distribution |
| 88935535 | Length 35.0 mm | In distribution |
| 1556001040 | In distribution | |
| 8377640 | In distribution | |
| 88925525 | Outer Diameter 5.5 mm | In distribution |
| 83555358 | In distribution | |
| 1556001075 | Length 75.0 mm | In distribution |
| X0209495 | Outer Diameter 7.5 mm | In distribution |
| X0607037 | Length 55.0 mm | In distribution |
| 83555609 | In distribution | |
| X0209473 | Outer Diameter 6.5 mm | In distribution |
| 83545506 | In distribution | |
| 9010000140 | Length 40.0 mm | In distribution |
| 83565359 | In distribution | |
| X0209516 | Length 60.0 mm | In distribution |
| 83565359H | Outer Diameter 6.5 mm | In distribution |
| 83555309 | In distribution | |
| 83565458 | In distribution | |
| 83565451 | Length 45.0 mm | In distribution |
| 83565406 | In distribution | |
| X0209512 | Outer Diameter 8.5 mm | In distribution |
| 83575306 | In distribution | |
| 83565356 | In distribution | |
| 88900105 | In distribution | |
| X0209447 | Outer Diameter 5.0 mm | In distribution |
| 83565309 | In distribution | |
| 83555606 | In distribution | |
| 83565556 | In distribution | |
| X0209436 | Outer Diameter 4.5 mm | In distribution |
| 83585606 | In distribution | |
| X0210194 | Length 45.0 mm | In distribution |
| 83585307 | In distribution | |
| 83585601 | Length 60.0 mm | In distribution |
| 83555558 | In distribution | |
| 83555259 | In distribution | |
| X0209468 | Length 45.0 mm | In distribution |
| 88937535 | Length 35.0 mm | In distribution |
| 83555601 | Length 60.0 mm | In distribution |
| X0310528 | Length 27.0 mm | In distribution |
| X0310529 | Length 45.0 mm | In distribution |
| 88936560 | Outer Diameter 6.5 mm | In distribution |
| X0209453 | Outer Diameter 5.0 mm | In distribution |
| 83575408 | In distribution | |
| 83565359 | In distribution | |
| 83565401 | Outer Diameter 6.5 mm | In distribution |
| 83565559 | In distribution | |
| 83555559H | Outer Diameter 5.5 mm | In distribution |
| X0209479 | Length 55.0 mm | In distribution |
| X0210170 | Length 30.0 mm | In distribution |
| X0209472 | Length 20.0 mm | In distribution |
| X0209507 | Outer Diameter 8.0 mm | In distribution |
| 88925555 | Outer Diameter 5.5 mm | In distribution |
| 88905512 | Length 12.0 mm | In distribution |
| X0607032 | Length 50.0 mm | In distribution |
| X0209448 | Length 35.0 mm | In distribution |
| 83545359 | In distribution | |
| 83565506 | In distribution | |
| 88945535 | Outer Diameter 5.5 mm | In distribution |
| 1556001105 | Length 105.0 mm | In distribution |
| 83545351 | Length 35.0 mm | In distribution |
| 83545309 | In distribution | |
| X0209499 | Length 20.0 mm | In distribution |
| X0209444 | Length 60.0 mm | In distribution |
| 8377655 | In distribution | |
| 83565559H | Length 55.0 mm | In distribution |
| 83575259 | In distribution | |
| X0209456 | Length 30.0 mm | In distribution |
| 8351520 | In distribution | |
| 88924520 | Length 20.0 mm | In distribution |
| 83575606 | In distribution | |
| X0209474 | Outer Diameter 6.5 mm | In distribution |
| 88937545 | Length 45.0 mm | In distribution |
| 83555301 | Length 30.0 mm | In distribution |
| 83575609H | Length 60.0 mm | In distribution |
| 83565408 | In distribution | |
| 83545606 | In distribution | |
| 9010000135 | Length 35.0 mm | In distribution |
| 83585406 | In distribution | |
| 1556001065 | Length 65.0 mm | In distribution |
| X0209492 | Outer Diameter 7.5 mm | In distribution |
| 83545359 | In distribution | |
| 83555356 | In distribution | |
| 83555556 | In distribution | |
| 1556001120 | Length 120.0 mm | In distribution |
| 83545306 | In distribution | |
| 83545456 | In distribution | |
| X0209464 | Outer Diameter 6.0 mm | In distribution |
| 1556000500 | Length 500.0 mm | In distribution |
| 88937540 | Length 40.0 mm | In distribution |
| 83545609H | Length 60.0 mm | In distribution |
| 83555209 | In distribution | |
| 83565606 | In distribution | |
| 83565554 | Outer Diameter 6.5 mm | In distribution |
| 88900111 | In distribution | |
| 88936525 | Outer Diameter 6.5 mm | In distribution |
| 83585409 | In distribution | |
| 83575451 | Outer Diameter 7.5 mm | In distribution |
| 88937530 | Outer Diameter 7.5 mm | In distribution |
| X0209483 | Length 30.0 mm | In distribution |
| 88905522 | Outer Diameter 5.5 mm | In distribution |
| 88948570 | Outer Diameter 8.5 mm | In distribution |
| 88926550 | Length 50.0 mm | In distribution |
| X0209489 | Outer Diameter 7.0 mm | In distribution |
| 83555357 | In distribution | |
| 83545356 | In distribution | |
| 88927535 | Outer Diameter 7.5 mm | In distribution |
| 83565454 | Length 45.0 mm | In distribution |
| 88934530 | Length 30.0 mm | In distribution |
| 83555359H | Length 35.0 mm | In distribution |
| 83555306 | In distribution | |
| 83585456 | In distribution | |
| 83555456 | In distribution | |
| 83565507 | In distribution | |
| 8281248 | In distribution | |
| 88937555 | Outer Diameter 7.5 mm | In distribution |
| 83555609 | In distribution | |
| 88936535 | Outer Diameter 6.5 mm | In distribution |
| X0607135 | In distribution | |
| 88900209 | In distribution | |
| 83585356 | In distribution | |
| X0210190 | Length 60.0 mm | In distribution |
| 83585357 | In distribution | |
| 1556001060 | Length 60.0 mm | In distribution |
| 83555457 | In distribution | |
| X1091-029 | In distribution | |
| 83565306 | In distribution | |
| 83585306 | In distribution | |
| 88927560 | Length 60.0 mm | In distribution |
| 83565601 | Length 60.0 mm | In distribution |
| 83565504 | Length 50.0 mm | In distribution |
| 8377555 | In distribution | |
| X0209491 | Outer Diameter 7.5 mm | In distribution |
| 88934535 | Outer Diameter 4.5 mm | In distribution |
| 88945540 | Outer Diameter 5.5 mm | In distribution |
| X0209466 | Outer Diameter 6.0 mm | In distribution |
| X0209503 | Length 40.0 mm | In distribution |
| 83575456 | In distribution | |
| X0210186 | Length 40.0 mm | In distribution |
| 88924540 | Length 40.0 mm | In distribution |
| 88924550 | Outer Diameter 4.5 mm | In distribution |
| X0209465 | Length 30.0 mm | In distribution |
| 88946535 | Outer Diameter 6.5 mm | In distribution |
| 83555459H | Length 45.0 mm | In distribution |
| 88938570 | Length 70.0 mm | Withdrawn |
| 88926025 | Outer Diameter 6.0 mm | Withdrawn |
| X8301541 | Length 41.0 cm | Withdrawn |
| 88946565 | Length 65.0 mm | Withdrawn |
| X0410052 | Length 65.0 mm | Withdrawn |
| X0310537 | Length 39.0 mm | Withdrawn |
| X0608012 | Length 20.0 mm | Withdrawn |
| 88936570 | Length 70.0 mm | Withdrawn |
| X0608009 | Length 50.0 mm | Withdrawn |
| 8376520 | Withdrawn | |
| X1206122 | Withdrawn | |
| 88937565 | Length 65.0 mm | Withdrawn |
| 8376660 | Withdrawn | |
| 88936020 | Outer Diameter 6.0 mm | Withdrawn |
| X0410055 | Length 70.0 mm | Withdrawn |
| X0608033 | Length 35.0 mm | Withdrawn |
| 88935020 | Outer Diameter 5.0 mm | Withdrawn |
| 88948500 | Outer Diameter 8.5 mm | Withdrawn |
| X09103824 | Length 40.0 mm | Withdrawn |
| X0310526 | Length 25.0 mm | Withdrawn |
| X0310535 | Length 35.0 mm | Withdrawn |
| X0510004 | Withdrawn | |
| 88948565 | Length 65.0 mm | Withdrawn |
| 8376750 | Withdrawn | |
| 8376745 | Withdrawn | |
| X0608018 | Length 50.0 mm | Withdrawn |
| 8376555 | Withdrawn | |
| X0309268 | Length 70.0 mm | Withdrawn |
| 88936050 | Length 50.0 mm | Withdrawn |
| X0410056 | Outer Diameter 8.5 mm | Withdrawn |
| X0310536 | Length 37.0 mm | Withdrawn |
| 88925560 | Length 60.0 mm | Withdrawn |
| 88938550 | Outer Diameter 8.5 mm | Withdrawn |
| X0608011 | Length 60.0 mm | Withdrawn |
| X0198-002 | Length 540.0 mm | Withdrawn |
| 8376635 | Withdrawn | |
| 88936030 | Length 30.0 mm | Withdrawn |
| X1206120 | Withdrawn | |
| 88926050 | Length 50.0 mm | Withdrawn |
| X0608029 | Length 60.0 mm | Withdrawn |
| 88926520 | Length 20.0 mm | Withdrawn |
| X0608008 | Length 45.0 mm | Withdrawn |
| 88936045 | Length 45.0 mm | Withdrawn |
| X09103834 | Length 55.0 mm | Withdrawn |
| 88936025 | Length 25.0 mm | Withdrawn |
| X0608010 | Length 55.0 mm | Withdrawn |
| 8376530 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170679 | 2017-05-11 |
| K140449 | 2014-03-25 |
| K123246 | 2012-11-16 |
| K122433 | 2012-09-28 |
| K121764 | 2012-08-21 |
| K113529 | 2012-02-09 |
| K112473 | 2011-10-21 |
| K111510 | 2011-09-15 |
| K111457 | 2011-09-15 |
| K110676 | 2011-05-23 |
| K103049 | 2010-12-23 |
| K102807 | 2010-11-17 |
| K101772 | 2010-09-30 |
| K091445 | 2010-09-27 |
| K091797 | 2010-04-30 |
| K093434 | 2009-12-02 |
| K093058 | 2009-10-26 |
| K092676 | 2009-10-02 |
| K090740 | 2009-08-14 |
| K091442 | 2009-07-15 |
| K090390 | 2009-05-15 |
| K081080 | 2008-11-21 |
| K082236 | 2008-10-10 |
| K062254 | 2008-06-16 |
| K072429 | 2007-09-28 |
| K063670 | 2007-06-28 |
| K063417 | 2007-01-18 |
| K063083 | 2006-11-06 |
| K062807 | 2006-11-06 |
| K060615 | 2006-10-25 |
| K061592 | 2006-07-03 |
| K060203 | 2006-02-13 |
| K053474 | 2006-01-06 |
| K053101 | 2006-01-05 |
| K052747 | 2005-10-28 |
| K052609 | 2005-10-21 |
| K052144 | 2005-08-31 |
| K052187 | 2005-08-22 |
| K052054 | 2005-08-16 |
| K050439 | 2005-03-24 |
| K043488 | 2005-03-21 |
| K050282 | 2005-02-18 |
| K043321 | 2005-02-03 |
| K042962 | 2004-12-14 |
| K042886 | 2004-11-18 |
| K042790 | 2004-11-04 |
| K042167 | 2004-09-08 |
| K032560 | 2004-03-09 |
| K032033 | 2003-09-12 |
| K030285 | 2003-02-25 |
Recalls Naming This Product
5 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 |
|---|---|---|---|---|---|---|---|
| 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.