E³ MIS Pedicle Screw System
Head Assembly, Mini Tower, 5.5mm , Titanium
11manufacturers in China registered for this device type
204catalogue numbers in this listing
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 | Degen Medical, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K173814 |
| Record published | 2018-04-18 |
| Record revised | 2022-09-16 (version 7) |
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 20 to 130 mm; outer diameter 4 to 10 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0602-65040 | Length 40 mm | In distribution |
| 0602-85045 | Length 45 mm | In distribution |
| 0602-10030 | Outer Diameter 10 mm | In distribution |
| 0603-10045 | Length 45 mm | In distribution |
| 0602-10070 | Outer Diameter 10 mm | In distribution |
| 0602-70075 | Length 75 mm | In distribution |
| 0602-80065 | Outer Diameter 8 mm | In distribution |
| 0603-70110 | Length 110 mm | In distribution |
| 0603-70050 | Length 50 mm | In distribution |
| 0602-90120 | Length 120 mm | In distribution |
| 0602-45020 | Length 20 mm | In distribution |
| 0602-95095 | Length 95 mm | In distribution |
| 0602-85035 | Outer Diameter 8.5 mm | In distribution |
| 0603-75060 | Length 60 mm | In distribution |
| 0603-50035 | Length 35 mm | In distribution |
| 0603-45050 | Length 50 mm | In distribution |
| 0603-80080 | Outer Diameter 8 mm | In distribution |
| 0603-70120 | Outer Diameter 7 mm | In distribution |
| 0602-10085 | Outer Diameter 10 mm | In distribution |
| 0602-95045 | Outer Diameter 9.5 mm | In distribution |
| 0602-90110 | Length 110 mm | In distribution |
| 0602-80045 | Length 45 mm | In distribution |
| 0603-45040 | Length 40 mm | In distribution |
| 0602-95040 | Length 40 mm | In distribution |
| 0602-75120 | Outer Diameter 7.5 mm | In distribution |
| 0603-90040 | Outer Diameter 9 mm | In distribution |
| 0603-75110 | Length 110 mm | In distribution |
| 0603-85050 | Length 50 mm | In distribution |
| 0603-80110 | Length 110 mm | In distribution |
| 0603-95065 | Length 65 mm | In distribution |
| 0603-95125 | Length 125 mm | In distribution |
| 0602-10130 | Length 130 mm | In distribution |
| 0602-65045 | Length 45 mm | In distribution |
| 0601-16M | In distribution | |
| 0603-80105 | Length 105 mm | In distribution |
| 0602-65085 | Length 85 mm | In distribution |
| 0603-90125 | Length 125 mm | In distribution |
| 0603-75130 | Outer Diameter 7.5 mm | In distribution |
| 0603-90105 | Length 105 mm | In distribution |
| 0603-45035 | Outer Diameter 4.5 mm | In distribution |
| 0603-70085 | Outer Diameter 7 mm | In distribution |
| 0602-60060 | Outer Diameter 6 mm | In distribution |
| 0603-10085 | Outer Diameter 10 mm | In distribution |
| 0603-80040 | Outer Diameter 8 mm | In distribution |
| 0603-70095 | Outer Diameter 7 mm | In distribution |
| 0602-45035 | Outer Diameter 4.5 mm | In distribution |
| 0602-65075 | Length 75 mm | In distribution |
| 06-29N | In distribution | |
| 0602-60050 | Length 50 mm | In distribution |
| 0602-95125 | Length 125 mm | In distribution |
| 0603-95070 | Length 70 mm | In distribution |
| 0601-17M | In distribution | |
| 0602-70035 | Length 35 mm | In distribution |
| 0602-75065 | Outer Diameter 7.5 mm | In distribution |
| 0603-70100 | Length 100 mm | In distribution |
| 0601-09M | In distribution | |
| 0602-95065 | Outer Diameter 9.5 mm | In distribution |
| 0603-90120 | Outer Diameter 9 mm | In distribution |
| 0602-45045 | Length 45 mm | In distribution |
| 0603-90080 | Length 80 mm | In distribution |
| 0602-75125 | Length 125 mm | In distribution |
| 0602-55060 | Length 60 mm | In distribution |
| 0602-90125 | Outer Diameter 9 mm | In distribution |
| 0602-75130 | Length 130 mm | In distribution |
| 0602-80110 | Outer Diameter 8 mm | In distribution |
| 0602-45025 | Outer Diameter 4.5 mm | In distribution |
| 0603-70070 | Outer Diameter 7 mm | In distribution |
| 0602-80070 | Outer Diameter 8 mm | In distribution |
| 0602-70090 | Length 90 mm | In distribution |
| 0602-75070 | Length 70 mm | In distribution |
| 0603-90065 | Length 65 mm | In distribution |
| 0603-10105 | Outer Diameter 10 mm | In distribution |
| 0603-65095 | Outer Diameter 6.5 mm | In distribution |
| 0602-85070 | Outer Diameter 8.5 mm | In distribution |
| 0602-65070 | Length 70 mm | In distribution |
| 0603-10050 | Outer Diameter 10 mm | In distribution |
| 0602-50020 | Length 20 mm | In distribution |
| 0603-85065 | Outer Diameter 8.5 mm | In distribution |
| 0603-65080 | Outer Diameter 6.5 mm | In distribution |
| 0602-50030 | Length 30 mm | In distribution |
| 0602-50060 | Length 60 mm | In distribution |
| 0603-70075 | Length 75 mm | In distribution |
| 0603-95105 | Length 105 mm | In distribution |
| 0602-80100 | Length 100 mm | In distribution |
| 0603-80070 | Length 70 mm | In distribution |
| 0603-10095 | Outer Diameter 10 mm | In distribution |
| 0603-85035 | Outer Diameter 8.5 mm | In distribution |
| 0602-70110 | Outer Diameter 7 mm | In distribution |
| 0602-80080 | Outer Diameter 8 mm | In distribution |
| 0602-90085 | Length 85 mm | In distribution |
| 0602-90115 | Length 115 mm | In distribution |
| 0602-65055 | Length 55 mm | In distribution |
| 0603-95095 | Outer Diameter 9.5 mm | In distribution |
| 0602-85095 | Outer Diameter 8.5 mm | In distribution |
| 0603-75050 | Length 50 mm | In distribution |
| 0602-65100 | Outer Diameter 6.5 mm | In distribution |
| 0602-80060 | Length 60 mm | In distribution |
| 0603-85070 | Length 70 mm | In distribution |
| 0603-95100 | Outer Diameter 9.5 mm | In distribution |
| 0602-80115 | Outer Diameter 8 mm | In distribution |
| 0602-75040 | Outer Diameter 7.5 mm | In distribution |
| 0603-60035 | Length 35 mm | In distribution |
| 0603-85120 | Length 120 mm | In distribution |
| 0602-70055 | Outer Diameter 7 mm | In distribution |
| 0602-90080 | Length 80 mm | In distribution |
| 0603-85130 | Outer Diameter 8.5 mm | In distribution |
| 0602-55040 | Length 40 mm | In distribution |
| 0602-10125 | Outer Diameter 10 mm | In distribution |
| 0603-50040 | Outer Diameter 5 mm | In distribution |
| 0602-95035 | Outer Diameter 9.5 mm | In distribution |
| 0603-90050 | Length 50 mm | In distribution |
| 0603-80115 | Outer Diameter 8 mm | In distribution |
| 0602-65035 | Length 35 mm | In distribution |
| 0602-75060 | Outer Diameter 7.5 mm | In distribution |
| 0603-60045 | Outer Diameter 6 mm | In distribution |
| 0602-10050 | Length 50 mm | In distribution |
| 0602-70130 | Outer Diameter 7 mm | In distribution |
| 0603-95090 | Outer Diameter 9.5 mm | In distribution |
| 0603-10080 | Outer Diameter 10 mm | In distribution |
| 0603-80095 | Outer Diameter 8 mm | In distribution |
| 0602-90045 | Outer Diameter 9 mm | In distribution |
| 0603-85090 | Length 90 mm | In distribution |
| 0603-85110 | Outer Diameter 8.5 mm | In distribution |
| 0603-10065 | Outer Diameter 10 mm | In distribution |
| 06-02N | In distribution | |
| 0603-80090 | Length 90 mm | In distribution |
| 0602-65080 | Outer Diameter 6.5 mm | In distribution |
| 0603-10055 | Length 55 mm | In distribution |
| 0602-55045 | Length 45 mm | In distribution |
| 0602-90070 | Outer Diameter 9 mm | In distribution |
| 0602-80090 | Outer Diameter 8 mm | In distribution |
| 0603-10120 | Length 120 mm | In distribution |
| 0602-80125 | Length 125 mm | In distribution |
| 0603-65060 | Outer Diameter 6.5 mm | In distribution |
| 0602-10075 | Outer Diameter 10 mm | In distribution |
| 0603-70115 | Outer Diameter 7 mm | In distribution |
| 0602-90030 | Outer Diameter 9 mm | In distribution |
| 0603-10130 | Length 130 mm | In distribution |
| 0603-65130 | Outer Diameter 6.5 mm | In distribution |
| 0602-55055 | Length 55 mm | In distribution |
| 0603-40025 | Length 25 mm | In distribution |
| 0603-10075 | Length 75 mm | In distribution |
| 0602-95050 | Outer Diameter 9.5 mm | In distribution |
| 0603-40030 | Length 30 mm | In distribution |
| 0602-85090 | Length 90 mm | In distribution |
| 0603-80075 | Length 75 mm | In distribution |
| 0602-60035 | Length 35 mm | In distribution |
| 0602-70040 | Length 40 mm | In distribution |
| 0602-50045 | Length 45 mm | In distribution |
| 0603-90075 | Outer Diameter 9 mm | In distribution |
| 0603-70040 | Outer Diameter 7 mm | In distribution |
| 0603-10115 | Length 115 mm | In distribution |
| 0603-70045 | Outer Diameter 7 mm | In distribution |
| 0603-90115 | Outer Diameter 9 mm | In distribution |
| 0602-70050 | Outer Diameter 7 mm | In distribution |
| 0602-80030 | Length 30 mm | In distribution |
| 0602-85100 | Length 100 mm | In distribution |
| 0603-90090 | Length 90 mm | In distribution |
| 0602-70100 | Outer Diameter 7 mm | In distribution |
| 0602-75050 | Outer Diameter 7.5 mm | In distribution |
| 0603-65065 | Length 65 mm | In distribution |
| 0603-65100 | Outer Diameter 6.5 mm | In distribution |
| 0603-95030 | Outer Diameter 9.5 mm | In distribution |
| 0602-80130 | Outer Diameter 8 mm | In distribution |
| 0602-70125 | Length 125 mm | In distribution |
| 0602-85050 | Length 50 mm | In distribution |
| 0603-80055 | Outer Diameter 8 mm | In distribution |
| 0602-65130 | Length 130 mm | In distribution |
| 0602-95090 | Outer Diameter 9.5 mm | In distribution |
| 0603-10110 | Length 110 mm | In distribution |
| 0602-90040 | Outer Diameter 9 mm | In distribution |
| 0602-85040 | Outer Diameter 8.5 mm | In distribution |
| 0603-45020 | Length 20 mm | In distribution |
| 0603-95080 | Length 80 mm | In distribution |
| 0602-95100 | Length 100 mm | In distribution |
| 06-03N | In distribution | |
| 0602-60040 | Length 40 mm | In distribution |
| 0603-70080 | Length 80 mm | In distribution |
| 0603-80120 | Length 120 mm | In distribution |
| 0603-85085 | Length 85 mm | In distribution |
| 0603-45025 | Length 25 mm | In distribution |
| 0602-45030 | Outer Diameter 4.5 mm | In distribution |
| 0603-90100 | Outer Diameter 9 mm | In distribution |
| 0602-95080 | Outer Diameter 9.5 mm | In distribution |
| 0602-10055 | Length 55 mm | In distribution |
| 0602-70065 | Outer Diameter 7 mm | In distribution |
| 0603-80060 | Outer Diameter 8 mm | In distribution |
| 0602-90095 | Outer Diameter 9 mm | In distribution |
| 0603-40045 | Outer Diameter 4 mm | In distribution |
| 0603-90035 | Outer Diameter 9 mm | In distribution |
| 0602-65115 | Length 115 mm | In distribution |
| 0602-75035 | Outer Diameter 7.5 mm | In distribution |
| 0602-10120 | Outer Diameter 10 mm | In distribution |
| 0603-95045 | Outer Diameter 9.5 mm | In distribution |
| 0603-60050 | Outer Diameter 6 mm | In distribution |
| 0603-70035 | Length 35 mm | In distribution |
| 0603-85125 | Outer Diameter 8.5 mm | In distribution |
| 0602-85125 | Length 125 mm | In distribution |
| 0602-85130 | Outer Diameter 8.5 mm | In distribution |
| 0603-65090 | Length 90 mm | In distribution |
| 0603-45055 | Outer Diameter 4.5 mm | In distribution |
| 0602-95070 | Outer Diameter 9.5 mm | In distribution |
| 0603-45030 | Outer Diameter 4.5 mm | In distribution |
| 0602-80050 | Length 50 mm | In distribution |
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
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.