FortiFix
FortiFix (C) Screw, Ø7.5mm x 45mm, Solid, Cort/Can, Nano
15manufacturers in China registered for this device type
112catalogue numbers in this listing
1510(k) clearance
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 | Nanovis Spine, LLC, 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) | K203452 |
| Record published | 2021-05-07 |
| Record revised | 2024-09-11 (version 5) |
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, expiry date, manufacturing date |
| Sizes | Outer diameter 5.5 to 8.5 mm; length 30 to 80 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12101-7545N | Outer Diameter 7.5 mm | In distribution |
| NV-916-0099 | In distribution | |
| 12001-5555N | Outer Diameter 5.5 mm | In distribution |
| 12005-7555N | Outer Diameter 7.5 mm | In distribution |
| 12005-6545N | Outer Diameter 6.5 mm | In distribution |
| NV-880-2001 | In distribution | |
| 12101-5535N | Outer Diameter 5.5 mm | In distribution |
| 12101-8580N | Outer Diameter 8.5 mm | In distribution |
| 12005-8575N | Outer Diameter 8.5 mm | In distribution |
| 12001-8550N | Outer Diameter 8.5 mm | In distribution |
| NV-908-1209 | In distribution | |
| 12001-7560N | Outer Diameter 7.5 mm | In distribution |
| NV-908-1202 | In distribution | |
| 12001-6560N | Outer Diameter 6.5 mm | In distribution |
| 12101-6540N | Outer Diameter 6.5 mm | In distribution |
| 12101-6530N | Outer Diameter 6.5 mm | In distribution |
| 12005-6555N | Outer Diameter 6.5 mm | In distribution |
| 12001-8575N | Outer Diameter 8.5 mm | In distribution |
| 12001-8580N | Outer Diameter 8.5 mm | In distribution |
| 12005-6560N | Outer Diameter 6.5 mm | In distribution |
| 12101-6535N | Outer Diameter 6.5 mm | In distribution |
| 12001-6555N | Outer Diameter 6.5 mm | In distribution |
| 12005-7560N | Outer Diameter 7.5 mm | In distribution |
| 12101-7550N | Outer Diameter 7.5 mm | In distribution |
| 12101-7555N | Outer Diameter 7.5 mm | In distribution |
| 12001-8540N | Outer Diameter 8.5 mm | In distribution |
| 12101-8560N | Outer Diameter 8.5 mm | In distribution |
| 12005-5550N | Outer Diameter 5.5 mm | In distribution |
| NV-908-1206 | In distribution | |
| NV-908-1201 | In distribution | |
| 12001-8565N | Outer Diameter 8.5 mm | In distribution |
| 12005-5535N | Outer Diameter 5.5 mm | In distribution |
| 12001-6550N | Outer Diameter 6.5 mm | In distribution |
| NV-100-1000 | In distribution | |
| NV-905-1205-2 | In distribution | |
| 12001-6540N | Outer Diameter 6.5 mm | In distribution |
| 12005-5530N | Outer Diameter 5.5 mm | In distribution |
| 12001-5545N | Outer Diameter 5.5 mm | In distribution |
| 12001-8570N | Outer Diameter 8.5 mm | In distribution |
| 12005-7550N | Outer Diameter 7.5 mm | In distribution |
| 12005-7545N | Outer Diameter 7.5 mm | In distribution |
| 12101-5555N | Outer Diameter 5.5 mm | In distribution |
| 12001-5550N | Outer Diameter 5.5 mm | In distribution |
| 12001-8545N | Outer Diameter 8.5 mm | In distribution |
| 12005-8565N | Outer Diameter 8.5 mm | In distribution |
| NV-880-2002 | In distribution | |
| NV-908-1203 | In distribution | |
| 12005-6540N | Outer Diameter 6.5 mm | In distribution |
| NV-908-0004 | In distribution | |
| 12101-7540N | Outer Diameter 7.5 mm | In distribution |
| 12101-5560N | Outer Diameter 5.5 mm | In distribution |
| 12005-6550N | Outer Diameter 6.5 mm | In distribution |
| 12001-7530N | Outer Diameter 7.5 mm | In distribution |
| 12001-5540N | Outer Diameter 5.5 mm | In distribution |
| 12005-7535N | Outer Diameter 7.5 mm | In distribution |
| 12005-6530N | Outer Diameter 6.5 mm | In distribution |
| 12005-6535N | Outer Diameter 6.5 mm | In distribution |
| NV-908-1210 | In distribution | |
| 12001-8560N | Outer Diameter 8.5 mm | In distribution |
| 12001-6530N | Outer Diameter 6.5 mm | In distribution |
| 12001-6545N | Outer Diameter 6.5 mm | In distribution |
| NV-908-1204 | In distribution | |
| NV-908-1208 | In distribution | |
| NV-908-1207 | In distribution | |
| 12001-5535N | Outer Diameter 5.5 mm | In distribution |
| 12005-8540N | Outer Diameter 8.5 mm | In distribution |
| 12001-7550N | Outer Diameter 7.5 mm | In distribution |
| 12001-8555N | Outer Diameter 8.5 mm | In distribution |
| 12005-7540N | Outer Diameter 7.5 mm | In distribution |
| 12101-6555N | Outer Diameter 6.5 mm | In distribution |
| 12005-8570N | Outer Diameter 8.5 mm | In distribution |
| 12001-6535N | Outer Diameter 6.5 mm | In distribution |
| 12001-7555N | Outer Diameter 7.5 mm | In distribution |
| 12101-6550N | Outer Diameter 6.5 mm | In distribution |
| 12005-8555N | Outer Diameter 8.5 mm | In distribution |
| 12101-7535N | Outer Diameter 7.5 mm | In distribution |
| 12101-8550N | Outer Diameter 8.5 mm | In distribution |
| 12005-8545N | Outer Diameter 8.5 mm | In distribution |
| 12101-5530N | Outer Diameter 5.5 mm | In distribution |
| 12001-7535N | Outer Diameter 7.5 mm | In distribution |
| 12101-8535N | Outer Diameter 8.5 mm | In distribution |
| 12005-5555N | Outer Diameter 5.5 mm | In distribution |
| 12001-5530N | Outer Diameter 5.5 mm | In distribution |
| 12005-8530N | Outer Diameter 8.5 mm | In distribution |
| 12101-8555N | Outer Diameter 8.5 mm | In distribution |
| 12005-5545N | Outer Diameter 5.5 mm | In distribution |
| 12005-5540N | Outer Diameter 5.5 mm | In distribution |
| 12101-6560N | Outer Diameter 6.5 mm | In distribution |
| 12101-5540N | Outer Diameter 5.5 mm | In distribution |
| 12005-8535N | Outer Diameter 8.5 mm | In distribution |
| 12101-5545N | Outer Diameter 5.5 mm | In distribution |
| 12101-8545N | Outer Diameter 8.5 mm | In distribution |
| 12101-8530N | Outer Diameter 8.5 mm | In distribution |
| 12005-5560N | Outer Diameter 5.5 mm | In distribution |
| 12001-8535N | Outer Diameter 8.5 mm | In distribution |
| 12001-8530N | Outer Diameter 8.5 mm | In distribution |
| 12101-6545N | Outer Diameter 6.5 mm | In distribution |
| 12001-5560N | Outer Diameter 5.5 mm | In distribution |
| NV-908-0003 | In distribution | |
| 12005-8560N | Outer Diameter 8.5 mm | In distribution |
| NV-880-1204 | In distribution | |
| NV-908-1205-2 | In distribution | |
| 12005-8550N | Outer Diameter 8.5 mm | In distribution |
| 12001-7545N | Outer Diameter 7.5 mm | In distribution |
| 12101-5550N | Outer Diameter 5.5 mm | In distribution |
| 12101-8540N | Outer Diameter 8.5 mm | In distribution |
| 12101-7530N | Outer Diameter 7.5 mm | In distribution |
| 12005-7530N | Outer Diameter 7.5 mm | In distribution |
| 12001-7540N | Outer Diameter 7.5 mm | In distribution |
| 12005-8580N | Outer Diameter 8.5 mm | In distribution |
| 12101-7560N | Outer Diameter 7.5 mm | In distribution |
| 12101-8570N | Outer Diameter 8.5 mm | In distribution |
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 |
|---|---|
| K193211 | 2020-03-20 |
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.