E³ MIS Pedicle Screw System
E3 MIS is a pedicle-screw fixation system with cannulated and non-cannulated screws designed to connect to 5.5 mm rods. Components are assembled into a rigid construct for stabilization of…
E3 MIS is a pedicle-screw fixation system with cannulated and non-cannulated screws designed to connect to 5.5 mm rods. Components are assembled into a rigid construct for stabilization of the thoracic, lumbar and sacral spine during fusion.
The system uses commercially pure titanium, titanium alloy and/or cobalt-chromium-molybdenum components. Screw dimensions and rod lengths vary to match the patient’s anatomy.
Listed Item
Spondy Head Assembly, 5.5mm, Titanium
System Compatibility
E3 MIS is specified for interchangeable use with the DeGen F1 MPS system, including CONNECT-L transverse connectors and JOUST minimally invasive rods. Components are supplied nonsterile. The pediatric indication is limited to posterior pedicle-screw fixation for adolescent idiopathic scoliosis with bone graft.
15manufacturers in China registered for this device type
213catalogue numbers in this listing
3510(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 | Degen Medical, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 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 |
|---|---|---|
| 0602-45040 | Length 40 mm | In distribution |
| 0602-50035 | Length 35 mm | In distribution |
| 0603-55055 | Length 55 mm | In distribution |
| 0603-65075 | Outer Diameter 6.5 mm | In distribution |
| 0603-75095 | Length 95 mm | In distribution |
| 0603-80085 | Length 85 mm | In distribution |
| 0602-90100 | Outer Diameter 9 mm | In distribution |
| 0603-70060 | Outer Diameter 7 mm | In distribution |
| 0602-50040 | Outer Diameter 5 mm | In distribution |
| 0603-80125 | Outer Diameter 8 mm | In distribution |
| 0603-65035 | Outer Diameter 6.5 mm | In distribution |
| 0602-80075 | Outer Diameter 8 mm | In distribution |
| 0602-10065 | Length 65 mm | In distribution |
| 0603-75085 | Length 85 mm | In distribution |
| 0603-50020 | Outer Diameter 5 mm | In distribution |
| 0602-60030 | Outer Diameter 6 mm | In distribution |
| 0602-85110 | Outer Diameter 8.5 mm | In distribution |
| 0603-75105 | Length 105 mm | In distribution |
| 0603-60055 | Outer Diameter 6 mm | In distribution |
| 0602-10115 | Length 115 mm | In distribution |
| 0603-50030 | Outer Diameter 5 mm | In distribution |
| 0602-10045 | Outer Diameter 10 mm | In distribution |
| 0602-90075 | Outer Diameter 9 mm | In distribution |
| 0602-70095 | Length 95 mm | In distribution |
| 0602-85120 | Length 120 mm | In distribution |
| 0603-55040 | Length 40 mm | In distribution |
| 0603-85040 | Length 40 mm | In distribution |
| 0603-60040 | Length 40 mm | In distribution |
| 0603-50045 | Outer Diameter 5 mm | In distribution |
| 0603-65070 | Length 70 mm | In distribution |
| 0603-65105 | Outer Diameter 6.5 mm | In distribution |
| 0602-50055 | Outer Diameter 5 mm | In distribution |
| 0602-70080 | Length 80 mm | In distribution |
| 0602-90105 | Length 105 mm | In distribution |
| 0603-70125 | Outer Diameter 7 mm | In distribution |
| 0602-85055 | Length 55 mm | In distribution |
| 0602-70120 | Outer Diameter 7 mm | In distribution |
| 0602-95085 | Outer Diameter 9.5 mm | In distribution |
| 0603-90095 | Outer Diameter 9 mm | In distribution |
| 0603-65085 | Length 85 mm | In distribution |
| 0603-95115 | Outer Diameter 9.5 mm | In distribution |
| 0603-10060 | Length 60 mm | In distribution |
| 0602-90055 | Length 55 mm | In distribution |
| 0603-10030 | Outer Diameter 10 mm | In distribution |
| 0603-10090 | Length 90 mm | In distribution |
| 0602-80095 | Length 95 mm | In distribution |
| 0603-80030 | Length 30 mm | In distribution |
| 0603-85045 | Length 45 mm | In distribution |
| 0602-90050 | Outer Diameter 9 mm | In distribution |
| 0603-95075 | Outer Diameter 9.5 mm | In distribution |
| 0603-50025 | Outer Diameter 5 mm | In distribution |
| 0603-40020 | Length 20 mm | In distribution |
| 0602-45060 | Outer Diameter 4.5 mm | In distribution |
| 0603-90110 | Length 110 mm | In distribution |
| 0602-10100 | Outer Diameter 10 mm | In distribution |
| 0603-75035 | Length 35 mm | In distribution |
| 0603-40050 | Length 50 mm | In distribution |
| 0603-40035 | Length 35 mm | In distribution |
| 0603-75030 | Length 30 mm | In distribution |
| 0602-10040 | Length 40 mm | In distribution |
| 0602-95030 | Length 30 mm | In distribution |
| 0603-95130 | Length 130 mm | In distribution |
| 0602-10080 | Length 80 mm | In distribution |
| 0603-95055 | Length 55 mm | In distribution |
| 0603-80045 | Length 45 mm | In distribution |
| 0602-75085 | Length 85 mm | In distribution |
| 0602-90090 | Outer Diameter 9 mm | In distribution |
| 0603-85095 | Outer Diameter 8.5 mm | In distribution |
| 0603-95035 | Length 35 mm | In distribution |
| 0602-90065 | Length 65 mm | In distribution |
| 0601-120M | In distribution | |
| 0603-55030 | Length 30 mm | In distribution |
| 0602-80105 | Outer Diameter 8 mm | In distribution |
| 0602-85105 | Outer Diameter 8.5 mm | In distribution |
| 0603-60030 | Length 30 mm | In distribution |
| 0603-90055 | Length 55 mm | In distribution |
| 0602-85080 | Length 80 mm | In distribution |
| 0603-45060 | Length 60 mm | In distribution |
| 0603-70105 | Length 105 mm | In distribution |
| 0602-75090 | Outer Diameter 7.5 mm | In distribution |
| 0603-80065 | Outer Diameter 8 mm | In distribution |
| 0603-75045 | Length 45 mm | In distribution |
| 0602-70045 | Length 45 mm | In distribution |
| 0602-75095 | Outer Diameter 7.5 mm | In distribution |
| 0603-75125 | Outer Diameter 7.5 mm | In distribution |
| 0602-65090 | Length 90 mm | In distribution |
| 0603-45045 | Length 45 mm | In distribution |
| 0602-55030 | Length 30 mm | In distribution |
| 0603-90030 | Length 30 mm | In distribution |
| 0603-90060 | Outer Diameter 9 mm | In distribution |
| 0602-70115 | Outer Diameter 7 mm | In distribution |
| 0603-75090 | Length 90 mm | In distribution |
| 0603-50060 | Outer Diameter 5 mm | In distribution |
| 0603-65040 | Length 40 mm | In distribution |
| 0602-90035 | Outer Diameter 9 mm | In distribution |
| 0603-75055 | Length 55 mm | In distribution |
| 0603-75100 | Length 100 mm | In distribution |
| 0603-75115 | Outer Diameter 7.5 mm | In distribution |
| 0602-50050 | Length 50 mm | In distribution |
| 0603-55060 | Length 60 mm | In distribution |
| 0602-75105 | Outer Diameter 7.5 mm | In distribution |
| 0603-10100 | Length 100 mm | In distribution |
| 0603-65045 | Outer Diameter 6.5 mm | In distribution |
| 0602-85065 | Outer Diameter 8.5 mm | In distribution |
| 0601-39M | In distribution | |
| 0602-80055 | Length 55 mm | In distribution |
| 0603-85105 | Length 105 mm | In distribution |
| 0603-65115 | Outer Diameter 6.5 mm | In distribution |
| 0602-75055 | Length 55 mm | In distribution |
| 0603-80035 | Outer Diameter 8 mm | In distribution |
| 0603-90045 | Length 45 mm | In distribution |
| 0603-95040 | Length 40 mm | In distribution |
| 0603-55045 | Length 45 mm | In distribution |
| 0602-45050 | Outer Diameter 4.5 mm | In distribution |
| 0603-75065 | Length 65 mm | In distribution |
| 0603-70055 | Outer Diameter 7 mm | In distribution |
| 0602-55035 | Length 35 mm | In distribution |
| 0602-65060 | Outer Diameter 6.5 mm | In distribution |
| 0603-60060 | Outer Diameter 6 mm | In distribution |
| 0603-50050 | Length 50 mm | In distribution |
| 0602-75110 | Length 110 mm | In distribution |
| 0603-50055 | Length 55 mm | In distribution |
| 0602-75075 | Length 75 mm | In distribution |
| 0602-70070 | Length 70 mm | In distribution |
| 0602-75100 | Outer Diameter 7.5 mm | In distribution |
| 0602-60045 | Outer Diameter 6 mm | In distribution |
| 0603-65050 | Length 50 mm | In distribution |
| 06-04N | In distribution | |
| 0603-10125 | Length 125 mm | In distribution |
| 0603-70090 | Length 90 mm | In distribution |
| 0602-55050 | Length 50 mm | In distribution |
| 0603-80050 | Length 50 mm | In distribution |
| 0603-40040 | Outer Diameter 4 mm | In distribution |
| 0603-75075 | Outer Diameter 7.5 mm | In distribution |
| 0603-10035 | Outer Diameter 10 mm | In distribution |
| 0602-65110 | Outer Diameter 6.5 mm | In distribution |
| 0602-10060 | Length 60 mm | In distribution |
| 0602-85030 | Length 30 mm | In distribution |
| 0602-65050 | Length 50 mm | In distribution |
| 0602-85075 | Outer Diameter 8.5 mm | In distribution |
| 0602-75115 | Length 115 mm | In distribution |
| 0603-80130 | Length 130 mm | In distribution |
| 0602-80085 | Length 85 mm | In distribution |
| 0602-10110 | Length 110 mm | In distribution |
| 0603-75040 | Length 40 mm | In distribution |
| 0602-90060 | Length 60 mm | In distribution |
| 0603-85080 | Length 80 mm | In distribution |
| 0603-95110 | Length 110 mm | In distribution |
| 0602-80040 | Outer Diameter 8 mm | In distribution |
| 0602-75080 | Outer Diameter 7.5 mm | In distribution |
| 0602-10095 | Length 95 mm | In distribution |
| 0602-80035 | Length 35 mm | In distribution |
| 0603-10040 | Outer Diameter 10 mm | In distribution |
| 0603-85030 | Length 30 mm | In distribution |
| 0603-95060 | Outer Diameter 9.5 mm | In distribution |
| 0602-10090 | Outer Diameter 10 mm | In distribution |
| 0602-50025 | Length 25 mm | In distribution |
| 0603-85100 | Outer Diameter 8.5 mm | In distribution |
| 0603-65110 | Outer Diameter 6.5 mm | In distribution |
| 0602-95055 | Outer Diameter 9.5 mm | In distribution |
| 0602-95075 | Outer Diameter 9.5 mm | In distribution |
| 0602-85115 | Length 115 mm | In distribution |
| 0602-70105 | Length 105 mm | In distribution |
| 0602-95060 | Length 60 mm | In distribution |
| 0603-90130 | Length 130 mm | In distribution |
| 0603-90070 | Outer Diameter 9 mm | In distribution |
| 0602-60055 | Outer Diameter 6 mm | In distribution |
| 0603-95120 | Outer Diameter 9.5 mm | In distribution |
| 0603-75080 | Outer Diameter 7.5 mm | In distribution |
| 0602-95110 | Length 110 mm | In distribution |
| 0602-95120 | Outer Diameter 9.5 mm | In distribution |
| 0602-65120 | Outer Diameter 6.5 mm | In distribution |
| 0603-95085 | Length 85 mm | In distribution |
| 0602-65105 | Length 105 mm | In distribution |
| 0602-65095 | Outer Diameter 6.5 mm | In distribution |
| 0603-85055 | Outer Diameter 8.5 mm | In distribution |
| 0603-65120 | Outer Diameter 6.5 mm | In distribution |
| 0603-70130 | Outer Diameter 7 mm | In distribution |
| 0602-85060 | Outer Diameter 8.5 mm | In distribution |
| 0603-70030 | Length 30 mm | In distribution |
| 0602-45055 | Length 55 mm | In distribution |
| 0602-95105 | Outer Diameter 9.5 mm | In distribution |
| 0602-95115 | Outer Diameter 9.5 mm | In distribution |
| 0603-65055 | Outer Diameter 6.5 mm | In distribution |
| 0603-65030 | Outer Diameter 6.5 mm | In distribution |
| 0602-85085 | Length 85 mm | In distribution |
| 0603-10070 | Length 70 mm | In distribution |
| 0602-70060 | Length 60 mm | In distribution |
| 0602-10105 | Length 105 mm | In distribution |
| 0603-75070 | Length 70 mm | In distribution |
| 0603-80100 | Length 100 mm | In distribution |
| 0602-65030 | Length 30 mm | In distribution |
| 0603-85075 | Outer Diameter 8.5 mm | In distribution |
| 0603-65125 | Outer Diameter 6.5 mm | In distribution |
| 0603-70065 | Length 65 mm | In distribution |
| 0602-75030 | Outer Diameter 7.5 mm | In distribution |
| 0602-75045 | Length 45 mm | In distribution |
| 0602-80120 | Length 120 mm | In distribution |
| 0603-55035 | Outer Diameter 5.5 mm | In distribution |
| 0602-65065 | Outer Diameter 6.5 mm | In distribution |
| 0603-55050 | Outer Diameter 5.5 mm | In distribution |
| 0603-90085 | Outer Diameter 9 mm | In distribution |
| 0602-70030 | Outer Diameter 7 mm | In distribution |
| 0601-121M | In distribution | |
| 0602-10035 | Length 35 mm | In distribution |
| 0603-85115 | Outer Diameter 8.5 mm | In distribution |
| 0602-70085 | Outer Diameter 7 mm | In distribution |
| 0603-75120 | Outer Diameter 7.5 mm | In distribution |
| 0602-90130 | Outer Diameter 9 mm | In distribution |
| 0603-95050 | Outer Diameter 9.5 mm | In distribution |
| 0602-65125 | Outer Diameter 6.5 mm | In distribution |
| 0603-85060 | Outer Diameter 8.5 mm | In distribution |
| 0602-95130 | Length 130 mm | In distribution |
Same Product Code
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|---|---|---|
| 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 |
|---|---|
| K173814 | 2018-01-29 |
| K160926 | 2016-06-28 |
| K142531 | 2015-03-20 |
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.