Tsrh® Spinal System
SCR X0209455 TSR3 21PS OG TI Hact 5.5X25
13manufacturers in China registered for this device type
214catalogue numbers in this listing
23510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 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 |
| 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 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spinal Pedicle Fixation
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K091797 |
| Record published | 2015-07-02 |
| Record revised | 2024-09-11 (version 7) |
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 3 to 90 mm; outer diameter 4.5 to 9.5 mm; width 6.5 to 8.5 mm |
| Distribution end date | 2025-12-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X0209455 | Length 25.0 mm | In distribution |
| 8371070 | Outer Diameter 6.35 mm | In distribution |
| 837-635 | Outer Diameter 6.5 mm | In distribution |
| 8371660 | Outer Diameter 6.5 mm | In distribution |
| 837-355 | Length 55.0 mm | In distribution |
| 83555408 | In distribution | |
| X0807106 | Outer Diameter 7.5 mm | In distribution |
| X0999018 | Length 40.0 mm | In distribution |
| X0209451 | Outer Diameter 5.0 mm | In distribution |
| 83565409 | In distribution | |
| X0807107 | Outer Diameter 7.5 mm | In distribution |
| 83575458 | In distribution | |
| X0592-005 | Length 3.0 mm | In distribution |
| 83555509H | Length 50.0 mm | In distribution |
| 8281246 | 1/4-32 | In distribution |
| 83565509H | Length 50.0 mm | In distribution |
| X0209500 | Outer Diameter 8.0 mm | In distribution |
| 88946530 | Length 30.0 mm | In distribution |
| X1091-041 | In distribution | |
| X0209508 | Length 20.0 mm | In distribution |
| 88947550 | Outer Diameter 7.5 mm | In distribution |
| 8370030 | In distribution | |
| X0209506 | Outer Diameter 8.0 mm | In distribution |
| 83565309 | In distribution | |
| 8372820 | Length 20.0 mm | In distribution |
| X0607028 | Length 45.0 mm | In distribution |
| 83585409H | Length 40.0 mm | In distribution |
| 83555459 | In distribution | |
| 8371650 | Length 50.0 mm | In distribution |
| 83575608 | In distribution | |
| 8370440 | Length 40.0 mm | In distribution |
| 8372660 | Width 6.5 mm | In distribution |
| 8377745 | In distribution | |
| 8377630 | In distribution | |
| 1556001090 | Length 90.0 mm | In distribution |
| 88944545 | Outer Diameter 4.5 mm | In distribution |
| X0807092 | Length 45.0 mm | In distribution |
| 8370060 | In distribution | |
| 8371730 | Outer Diameter 7.5 mm | In distribution |
| 83565509 | In distribution | |
| 83575509 | In distribution | |
| 88925040 | Outer Diameter 5.0 mm | In distribution |
| 83555259 | In distribution | |
| 8372845 | Length 45.0 mm | In distribution |
| X0807111 | Length 50.0 mm | In distribution |
| X837-645 | Length 45.0 mm | In distribution |
| X0607035 | Length 45.0 mm | In distribution |
| X0209440 | Outer Diameter 4.5 mm | In distribution |
| 83545401 | Length 40.0 mm | In distribution |
| 83565409H | Length 40.0 mm | In distribution |
| 837-230 | Length 30.0 mm | In distribution |
| 83545259H | Outer Diameter 4.5 mm | In distribution |
| 8371530 | Outer Diameter 5.5 mm | In distribution |
| X0807102 | Outer Diameter 6.5 mm | In distribution |
| 83575409H | Length 40.0 mm | In distribution |
| X1194-760 | Length 60.0 mm | In distribution |
| X0209493 | Length 35.0 mm | In distribution |
| X0209487 | Outer Diameter 7.0 mm | In distribution |
| 88947525 | Length 25.0 mm | In distribution |
| X1194-709 | Outer Diameter 7.0 mm | In distribution |
| X0209477 | Length 45.0 mm | In distribution |
| 83575309H | Length 30.0 mm | In distribution |
| 83565251 | Outer Diameter 6.5 mm | In distribution |
| X0209461 | Length 55.0 mm | In distribution |
| 83545451 | Length 45.0 mm | In distribution |
| 88925550 | Length 50.0 mm | In distribution |
| 8370035 | In distribution | |
| 88900210 | In distribution | |
| 8377735 | In distribution | |
| 1556001080 | In distribution | |
| X0204038 | 6.5mm THROAT | In distribution |
| 88945530 | Outer Diameter 5.5 mm | In distribution |
| 83545309 | In distribution | |
| X0209454 | Length 20.0 mm | In distribution |
| X0807094 | Length 55.0 mm | In distribution |
| 83555559 | In distribution | |
| X0592-002 | Length 6.0 mm | In distribution |
| 83555508 | In distribution | |
| X8372935 | Length 35.0 mm | In distribution |
| 83565508 | In distribution | |
| 8370430 | Outer Diameter 4.5 mm | In distribution |
| 88901000 | In distribution | |
| 8371080 | Outer Diameter 6.35 mm | In distribution |
| X0209511 | Length 35.0 mm | In distribution |
| 837-345 | Length 45.0 mm | In distribution |
| X1194-603 | Outer Diameter 6.0 mm | In distribution |
| 83575409 | In distribution | |
| 88945030 | Length 30.0 mm | In distribution |
| 88946525 | Length 25.0 mm | In distribution |
| X0608090 | Length 50.0 mm | In distribution |
| X0607136 | In distribution | |
| 83575309 | In distribution | |
| 8379140 | In distribution | |
| 88900213 | In distribution | |
| 8371755 | Length 55.0 mm | In distribution |
| 8371035 | Length 35.0 mm | In distribution |
| 8370065 | Length 65.0 mm | In distribution |
| 83575459 | In distribution | |
| 83545509 | In distribution | |
| 8376540 | In distribution | |
| X0209502 | Length 35.0 mm | In distribution |
| 9010000150 | Length 50.0 mm | In distribution |
| 88945040 | Length 40.0 mm | In distribution |
| 83565551 | Length 55.0 mm | In distribution |
| X0209497 | Outer Diameter 7.5 mm | In distribution |
| 8377535 | In distribution | |
| 8372525 | Length 25.0 mm | In distribution |
| 837-435 | Outer Diameter 7.5 mm | In distribution |
| 8372855 | Width 8.5 mm | In distribution |
| 83565458 | In distribution | |
| 88900207 | In distribution | |
| 88945555 | Length 55.0 mm | In distribution |
| 8371550 | Outer Diameter 5.5 mm | In distribution |
| 8371090 | Outer Diameter 6.35 mm | In distribution |
| X0592-003 | Outer Diameter 7.5 mm | In distribution |
| 8377550 | In distribution | |
| 88925545 | Outer Diameter 5.5 mm | In distribution |
| 83565608 | In distribution | |
| X0209470 | Length 55.0 mm | In distribution |
| 83565301 | Length 30.0 mm | In distribution |
| 837-430 | Outer Diameter 7.5 mm | In distribution |
| X0792-012 | Length 9.0 mm | In distribution |
| X0807096 | Outer Diameter 6.5 mm | In distribution |
| X0209505 | Length 50.0 mm | In distribution |
| X0607029 | Length 50.0 mm | In distribution |
| 83565358 | In distribution | |
| 8370090 | Outer Diameter 5.5 mm | In distribution |
| 83565459H | Length 45.0 mm | In distribution |
| 8370055 | Outer Diameter 5.5 mm | In distribution |
| X0807097 | Outer Diameter 6.5 mm | In distribution |
| 88947555 | Outer Diameter 7.5 mm | In distribution |
| 83585501 | Outer Diameter 8.5 mm | In distribution |
| X1091-031 | In distribution | |
| X0209509 | Length 25.0 mm | In distribution |
| 83575201 | Outer Diameter 7.5 mm | In distribution |
| 8281190 | Screw Thread 1/4 – 32 | In distribution |
| 8351502 | In distribution | |
| 1556001030 | Length 30.0 mm | In distribution |
| 88945055 | Length 55.0 mm | In distribution |
| X0209450 | Length 45.0 mm | In distribution |
| 83555209H | Length 20.0 mm | In distribution |
| 837-655 | Length 55.0 mm | In distribution |
| X0807091 | Length 40.0 mm | In distribution |
| X1198-033 | Length 60.0 mm | In distribution |
| 1556001090 | In distribution | |
| 83585509 | In distribution | |
| 83545301 | Outer Diameter 4.5 mm | In distribution |
| 8371030 | Outer Diameter 6.35 mm | In distribution |
| 8370080 | Length 80.0 mm | In distribution |
| 83545459 | In distribution | |
| 837-535 | Length 35.0 mm | In distribution |
| X0608088 | Length 40.0 mm | In distribution |
| 8372835 | Width 8.5 mm | In distribution |
| 83545509 | In distribution | |
| 8372645 | Width 6.5 mm | In distribution |
| 83575301 | Outer Diameter 7.5 mm | In distribution |
| 8372625 | Width 6.5 mm | In distribution |
| X0209443 | Length 55.0 mm | In distribution |
| 8377660 | In distribution | |
| 83545559H | Outer Diameter 4.5 mm | In distribution |
| 8351522 | In distribution | |
| 88926545 | Outer Diameter 6.5 mm | In distribution |
| 88946555 | Outer Diameter 6.5 mm | In distribution |
| 811-500 | Withdrawn | |
| 88927525 | Outer Diameter 7.5 mm | Withdrawn |
| X0410057 | Length 70.0 mm | Withdrawn |
| X09103833 | Length 50.0 mm | Withdrawn |
| X0311204 | Outer Diameter 5.5 mm | Withdrawn |
| X0702840 | Outer Diameter 6.5 mm | Withdrawn |
| 88948525 | Outer Diameter 8.5 mm | Withdrawn |
| 8379132C | Withdrawn | |
| 88934545 | Length 45.0 mm | Withdrawn |
| 8376545 | Withdrawn | |
| X0608022 | Length 25.0 mm | Withdrawn |
| 88928565 | Length 65.0 mm | Withdrawn |
| X0608007 | Length 40.0 mm | Withdrawn |
| 837-845 | Length 45.0 mm | Withdrawn |
| X1206125 | Withdrawn | |
| X0608027 | Length 50.0 mm | Withdrawn |
| X0310532 | Length 29.0 mm | Withdrawn |
| X0608030 | Length 20.0 mm | Withdrawn |
| 88934555 | Length 55.0 mm | Withdrawn |
| 8379131C | Withdrawn | |
| 8376535 | Withdrawn | |
| X0309267 | Length 65.0 mm | Withdrawn |
| X0702935 | Outer Diameter 7.5 mm | Withdrawn |
| 808-151 | Withdrawn | |
| 804-205 | Withdrawn | |
| 8371840 | Length 40.0 mm | Withdrawn |
| 8376625 | Withdrawn | |
| X0608037 | Length 55.0 mm | Withdrawn |
| X0608034 | Length 40.0 mm | Withdrawn |
| X0204860 | Outer Diameter 8.5 mm | Withdrawn |
| X0410053 | Outer Diameter 6.5 mm | Withdrawn |
| 88926060 | Outer Diameter 6.0 mm | Withdrawn |
| 8376650 | Withdrawn | |
| X1206124 | Withdrawn | |
| X0608038 | Length 60.0 mm | Withdrawn |
| X0310530 | Length 25.0 mm | Withdrawn |
| X0202635 | Length 35.0 mm | Withdrawn |
| X0607080 | Length 50.0 mm | Withdrawn |
| 88936060 | Length 60.0 mm | Withdrawn |
| X187027545 | Length 45.0 mm | Withdrawn |
| X0608032 | Length 30.0 mm | Withdrawn |
| 88936040 | Outer Diameter 6.0 mm | Withdrawn |
| 8371855 | Outer Diameter 8.5 mm | Withdrawn |
| X0608024 | Length 35.0 mm | Withdrawn |
| X0204850 | Outer Diameter 8.5 mm | Withdrawn |
| 810-222 | Withdrawn | |
| 8371860 | Length 60.0 mm | Withdrawn |
| 828-149 | Withdrawn | |
| 8371850 | Length 50.0 mm | Withdrawn |
| 8376740 | Withdrawn | |
| X0608021 | Length 20.0 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K062879 | 2006-12-22 |
| K062606 | 2006-09-25 |
| K053483 | 2006-01-05 |
| K042210 | 2004-11-04 |
| K042453 | 2004-10-07 |
| K041777 | 2004-09-03 |
| K041030 | 2004-06-30 |
| K041118 | 2004-05-28 |
| K040583 | 2004-03-31 |
| K033495 | 2003-12-03 |
| K033271 | 2003-11-06 |
| K031967 | 2003-09-17 |
| K032578 | 2003-09-17 |
| K032037 | 2003-09-04 |
| K031833 | 2003-09-03 |
| K031888 | 2003-06-27 |
| K030932 | 2003-05-16 |
| K030840 | 2003-05-15 |
| K022778 | 2002-09-18 |
| K021106 | 2002-05-03 |
| K011029 | 2001-06-05 |
| K011067 | 2001-05-04 |
| K000991 | 2000-04-18 |
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.