Erisma®-LP
Self retaining set screw driver
13manufacturers in China registered for this device type
207catalogue numbers in this listing
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 | Clariance, Inc., United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K153326 |
| Record published | 2016-04-08 |
| Record revised | 2024-11-11 (version 4) |
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 | Outer diameter 1.5 to 10.5 mm; length 20 to 500 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 18515220 | Outer Diameter 5.5 mm | In distribution |
| 13035540 | Outer Diameter 5.5 mm | In distribution |
| 18505070 | Outer Diameter 5.5 mm | In distribution |
| 18171035 | Length 35 mm | In distribution |
| 13011010 | Outer Diameter 10.5 mm | In distribution |
| 13037525 | Outer Diameter 7.5 mm | In distribution |
| 18168545 | Length 45 mm | In distribution |
| 13435090 | Length 90 mm | In distribution |
| 13719006 | In distribution | |
| 13731000 | In distribution | |
| 13038535 | Outer Diameter 8.5 mm | In distribution |
| 13039585 | Outer Diameter 9.5 mm | In distribution |
| 13031065 | Outer Diameter 10.5 mm | In distribution |
| 18118580 | Length 80 mm | In distribution |
| 13016520 | Outer Diameter 6.5 mm | In distribution |
| 18119530 | Length 30 mm | In distribution |
| 13011030 | Outer Diameter 10.5 mm | In distribution |
| 13031085 | Outer Diameter 10.5 mm | In distribution |
| 18171065 | Length 65 mm | In distribution |
| 13016540 | Outer Diameter 6.5 mm | In distribution |
| 18171095 | Length 95 mm | In distribution |
| 18171055 | Length 55 mm | In distribution |
| 18169595 | Length 95 mm | In distribution |
| 13017585 | Outer Diameter 7.5 mm | In distribution |
| 18171085 | Length 85 mm | In distribution |
| 13495070 | Length 70 mm | In distribution |
| 13039575 | Outer Diameter 9.5 mm | In distribution |
| 18168585 | Length 85 mm | In distribution |
| 18169545 | Length 45 mm | In distribution |
| 18159510 | Outer Diameter 9.5 mm | In distribution |
| 18744005 | In distribution | |
| 13710000 | In distribution | |
| 18166535 | Length 35 mm | In distribution |
| 18159570 | Outer Diameter 9.5 mm | In distribution |
| 13017525 | Outer Diameter 7.5 mm | In distribution |
| 18158580 | Outer Diameter 8.5 mm | In distribution |
| 18158540 | Outer Diameter 8.5 mm | In distribution |
| 13016530 | Outer Diameter 6.5 mm | In distribution |
| 18701195 | Outer Diameter 9.5 mm | In distribution |
| 13039595 | Outer Diameter 9.5 mm | In distribution |
| 13709050 | Length 500 mm | In distribution |
| 18721002 | In distribution | |
| 13037535 | Outer Diameter 7.5 mm | In distribution |
| 13038595 | Outer Diameter 8.5 mm | In distribution |
| 18119540 | Length 40 mm | In distribution |
| 13038565 | Outer Diameter 8.5 mm | In distribution |
| 15720001 | In distribution | |
| 18505110 | Outer Diameter 5.5 mm | In distribution |
| 18118530 | Length 30 mm | In distribution |
| 13031025 | Outer Diameter 10.5 mm | In distribution |
| 13039545 | Outer Diameter 9.5 mm | In distribution |
| 18158560 | Outer Diameter 8.5 mm | In distribution |
| 18515260 | Outer Diameter 5.5 mm | In distribution |
| 18118560 | Length 60 mm | In distribution |
| 13038585 | Outer Diameter 8.5 mm | In distribution |
| 18719002 | In distribution | |
| 13722005 | In distribution | |
| 18167565 | Length 65 mm | In distribution |
| 18710002 | In distribution | |
| 13019555 | Outer Diameter 9.5 mm | In distribution |
| 13031045 | Outer Diameter 10.5 mm | In distribution |
| 13011070 | Outer Diameter 10.5 mm | In distribution |
| 13495360 | Outer Diameter 5.5 mm | In distribution |
| 13034520 | Outer Diameter 4.5 mm | In distribution |
| 13037565 | Outer Diameter 7.5 mm | In distribution |
| 18167535 | Length 35 mm | In distribution |
| 18159580 | Outer Diameter 9.5 mm | In distribution |
| 13018585 | Outer Diameter 8.5 mm | In distribution |
| 18119570 | Length 70 mm | In distribution |
| 18171025 | Length 25 mm | In distribution |
| 13780000 | In distribution | |
| 18169555 | Length 55 mm | In distribution |
| 13038545 | Outer Diameter 8.5 mm | In distribution |
| 18710017 | In distribution | |
| 18171075 | Length 75 mm | In distribution |
| 18710004 | In distribution | |
| 18168575 | Length 75 mm | In distribution |
| 13435110 | Length 110 mm | In distribution |
| 18155555 | Length 55 mm | In distribution |
| 18505090 | Outer Diameter 5.5 mm | In distribution |
| 13707001 | In distribution | |
| 18168525 | Length 25 mm | In distribution |
| 13019575 | Length 75 mm | In distribution |
| 13037555 | Outer Diameter 7.5 mm | In distribution |
| 18171045 | Length 45 mm | In distribution |
| 13039555 | Outer Diameter 9.5 mm | In distribution |
| 13719003 | In distribution | |
| 18515340 | Outer Diameter 5.5 mm | In distribution |
| 18710025 | In distribution | |
| 13911004 | In distribution | |
| 13037585 | Outer Diameter 7.5 mm | In distribution |
| 13031095 | Outer Diameter 10.5 mm | In distribution |
| 18720003 | In distribution | |
| 13017595 | Outer Diameter 7.5 mm | In distribution |
| 13031075 | Outer Diameter 10.5 mm | In distribution |
| 18721007 | In distribution | |
| 13747002 | In distribution | |
| 18165550 | Length 50 mm | In distribution |
| 13711000 | In distribution | |
| 13435040 | Length 40 mm | In distribution |
| 18168535 | Length 35 mm | In distribution |
| 13495140 | Length 140 mm | In distribution |
| 18169575 | Length 75 mm | In distribution |
| 13036535 | Outer Diameter 6.5 mm | In distribution |
| 13018545 | Outer Diameter 8.5 mm | In distribution |
| 98715000 | In distribution | |
| 13031055 | Outer Diameter 10.5 mm | In distribution |
| 18169535 | Length 35 mm | In distribution |
| 18167595 | Length 95 mm | In distribution |
| 18118590 | Length 90 mm | In distribution |
| 18118510 | Length 100 mm | In distribution |
| 13435070 | Length 70 mm | In distribution |
| 13742000 | In distribution | |
| 18119550 | Length 50 mm | In distribution |
| 13018595 | Outer Diameter 8.5 mm | In distribution |
| 13038555 | Outer Diameter 8.5 mm | In distribution |
| 13011040 | Outer Diameter 10.5 mm | In distribution |
| 18169585 | Length 85 mm | In distribution |
| 18118570 | Length 70 mm | In distribution |
| 18168595 | Length 95 mm | In distribution |
| 13035530 | Outer Diameter 5.5 mm | In distribution |
| 13709040 | Length 400 mm | In distribution |
| 18721004 | In distribution | |
| 13021025 | Outer Diameter 10.5 mm | In distribution |
| 13017565 | Outer Diameter 7.5 mm | In distribution |
| 13018575 | Outer Diameter 8.5 mm | In distribution |
| 18167525 | Length 25 mm | In distribution |
| 18119560 | Length 60 mm | In distribution |
| 18720011 | In distribution | |
| 18174520 | Length 20 mm | In distribution |
| 18515140 | Outer Diameter 5.5 mm | In distribution |
| 18158590 | Outer Diameter 8.5 mm | In distribution |
| 15742004 | In distribution | |
| 13021035 | Outer Diameter 10.5 mm | In distribution |
| 13495400 | Outer Diameter 5.5 mm | In distribution |
| 13037595 | Outer Diameter 7.5 mm | In distribution |
| 18169525 | Length 25 mm | In distribution |
| 18714000 | In distribution | |
| 18159590 | Outer Diameter 9.5 mm | In distribution |
| 18168555 | Length 55 mm | In distribution |
| 13017555 | Outer Diameter 7.5 mm | In distribution |
| 13037575 | Outer Diameter 7.5 mm | In distribution |
| 18722001 | In distribution | |
| 18158550 | Outer Diameter 8.5 mm | In distribution |
| 13011060 | Outer Diameter 10.5 mm | In distribution |
| 13037545 | Outer Diameter 7.5 mm | In distribution |
| 13018525 | Outer Diameter 8.5 mm | In distribution |
| 13017535 | Outer Diameter 7.5 mm | In distribution |
| 18167585 | Length 85 mm | In distribution |
| 13435030 | Length 30 mm | In distribution |
| 13015550 | Outer Diameter 5.5 mm | In distribution |
| 18169565 | Length 65 mm | In distribution |
| 18710030 | In distribution | |
| 18119580 | Length 80 mm | In distribution |
| 13019525 | Outer Diameter 9.5 mm | In distribution |
| 18515180 | Outer Diameter 5.5 mm | In distribution |
| 13017575 | Outer Diameter 7.5 mm | In distribution |
| 13038575 | Outer Diameter 8.5 mm | In distribution |
| 18159540 | Outer Diameter 9.5 mm | In distribution |
| 13722001 | In distribution | |
| 18166525 | Length 25 mm | In distribution |
| 13495030 | Length 30 mm | In distribution |
| 18166555 | Length 55 mm | In distribution |
| 13039525 | Outer Diameter 9.5 mm | In distribution |
| 13039565 | Outer Diameter 9.5 mm | In distribution |
| 13031035 | Outer Diameter 10.5 mm | In distribution |
| 18167545 | Length 45 mm | In distribution |
| 13015540 | Outer Diameter 5.5 mm | In distribution |
| 18710023 | In distribution | |
| 13495280 | Outer Diameter 5.5 mm | In distribution |
| 18119590 | Length 90 mm | In distribution |
| 13034540 | Outer Diameter 4.5 mm | In distribution |
| 13019535 | Outer Diameter 9.5 mm | In distribution |
| 18158510 | Outer Diameter 8.5 mm | In distribution |
| 13011080 | Outer Diameter 10.5 mm | In distribution |
| 13015520 | Outer Diameter 5.5 mm | In distribution |
| 18159550 | Outer Diameter 9.5 mm | In distribution |
| 18167575 | Length 75 mm | In distribution |
| 13036555 | Outer Diameter 6.5 mm | In distribution |
| 13495320 | Outer Diameter 5.5 mm | In distribution |
| 13035520 | Outer Diameter 5.5 mm | In distribution |
| 13495240 | Outer Diameter 5.5 mm | In distribution |
| 13034530 | Outer Diameter 4.5 mm | In distribution |
| 13019565 | Length 65 mm | In distribution |
| 13038525 | Outer Diameter 8.5 mm | In distribution |
| 13019595 | Length 95 mm | In distribution |
| 13036545 | Outer Diameter 6.5 mm | In distribution |
| 13721001 | In distribution | |
| 13733002 | In distribution | |
| 13035550 | Outer Diameter 5.5 mm | In distribution |
| 13018535 | Outer Diameter 8.5 mm | In distribution |
| 13495050 | Length 50 mm | In distribution |
| 18168565 | Length 65 mm | In distribution |
| 18118540 | Length 40 mm | In distribution |
| 18118550 | Length 50 mm | In distribution |
| 13039535 | Outer Diameter 9.5 mm | In distribution |
| 18166545 | Length 45 mm | In distribution |
| 13019545 | Outer Diameter 9.5 mm | In distribution |
| 13018555 | Outer Diameter 8.5 mm | In distribution |
| 18158570 | Outer Diameter 8.5 mm | In distribution |
| 13495440 | Outer Diameter 5.5 mm | In distribution |
| 13036525 | Outer Diameter 6.5 mm | In distribution |
| 18720001 | In distribution | |
| 18167555 | Length 55 mm | In distribution |
| 18159560 | Outer Diameter 9.5 mm | In distribution |
| 18515300 | Outer Diameter 5.5 mm | In distribution |
| 18119510 | Length 100 mm | In distribution |
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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Clariance, Inc. | 510(k) number | 2019-07-01 | Class III | Use error | Potential for the polyaxial screw to become disassembled during implant. | 4,090 units distributed in the US | 2020-07-09 |
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.