Fortex Pedicle Screw System
ASSEMBLY, FORTEX MINI REDUCTION, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 50
13manufacturers in China registered for this device type
558catalogue numbers in this listing
4recalls on this 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, Spondylolisthesis Spinal Fixation
Record
| Listed by | Xtant Medical Holdings, Inc., United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K090224 |
| Record published | 2015-10-19 |
| Record revised | 2024-11-20 (version 6) |
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 30 to 500 mm; outer diameter 4.75 to 8.25 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X022-6540SD | Length 40 mm | In distribution |
| X077-0417 | Outer Diameter 5.5 mm | In distribution |
| X064-82540C-DL | Outer Diameter 8.25 mm | In distribution |
| C010-0068 | In distribution | |
| X064-82545C | Outer Diameter 8.25 mm | In distribution |
| X077-0400 | Outer Diameter 5.5 mm | In distribution |
| X064-5535-DL | Outer Diameter 5.5 mm | In distribution |
| X064-0081 | Length 35 mm | In distribution |
| X064-82550-DL | Outer Diameter 8.25 mm | In distribution |
| X010-0158 | In distribution | |
| X077-0500 | Outer Diameter 5.5 mm | In distribution |
| X064-7550SD-DL | Length 50 mm | In distribution |
| X077-0416 | Outer Diameter 5.5 mm | In distribution |
| X064-5530 | Outer Diameter 5.5 mm | In distribution |
| X077-0415 | Length 140 mm | In distribution |
| X022-0004 | Outer Diameter 4.75 mm | In distribution |
| C022-0017-2 | In distribution | |
| N60001101 | Outer Diameter 5.5 mm | In distribution |
| C010-0039 | In distribution | |
| X064-0007-DL | Length 30 mm | In distribution |
| X064-82535 | Length 35 mm | In distribution |
| X064-82535-DL | Outer Diameter 8.25 mm | In distribution |
| X077-0402 | Outer Diameter 5.5 mm | In distribution |
| X022-6530SD-DL | Length 30 mm | In distribution |
| X064-0005-DL | Outer Diameter 4.75 mm | In distribution |
| N60001095 | Length 65 mm | In distribution |
| X064-0109 | Outer Diameter 8.25 mm | In distribution |
| X064-0100-DL | Outer Diameter 7.5 mm | In distribution |
| X022-5550SD-DL | Length 50 mm | In distribution |
| X064-5535 | Outer Diameter 5.5 mm | In distribution |
| X077-0608 | Length 75 mm | In distribution |
| X064-82545 | Length 45 mm | In distribution |
| X064-0027 | Length 40 mm | In distribution |
| X064-0019 | Length 30 mm | In distribution |
| X022-6550SD | Length 50 mm | In distribution |
| X022-5540SD | Length 40 mm | In distribution |
| X064-7530 | Length 30 mm | In distribution |
| X077-0414 | Outer Diameter 5.5 mm | In distribution |
| X064-0004 | Length 45 mm | In distribution |
| X064-47555-DL | Outer Diameter 4.75 mm | In distribution |
| X077-0405 | Length 60 mm | In distribution |
| X064-0106 | Length 40 mm | In distribution |
| X064-7535C | Length 35 mm | In distribution |
| X022-0107 | Outer Diameter 8.25 mm | In distribution |
| X077-0613 | Outer Diameter 5.5 mm | In distribution |
| X064-0001 | Outer Diameter 4.75 mm | In distribution |
| X064-0010 | Length 45 mm | In distribution |
| X022-0012 | Outer Diameter 5.5 mm | In distribution |
| X064-0002 | Length 35 mm | In distribution |
| X064-6535-DL | Length 35 mm | In distribution |
| X064-0098-DL | Length 30 mm | In distribution |
| X077-0617 | Outer Diameter 5.5 mm | In distribution |
| X077-0519 | Outer Diameter 5.5 mm | In distribution |
| X022-0083 | Outer Diameter 4.75 mm | In distribution |
| N60001091 | Length 35 mm | In distribution |
| X064-0140 | In distribution | |
| X064-7550C | Outer Diameter 7.5 mm | In distribution |
| X077-0516 | Outer Diameter 5.5 mm | In distribution |
| X064-5555 | Length 55 mm | In distribution |
| X022-5540SD-DL | Outer Diameter 5.5 mm | In distribution |
| X077-0717 | Outer Diameter 5.5 mm | In distribution |
| X064-47535C-DL | Outer Diameter 4.75 mm | In distribution |
| X064-7545 | Length 45 mm | In distribution |
| X022-0107-DL | Length 45 mm | In distribution |
| X077-0506 | Length 65 mm | In distribution |
| N60001102 | Length 130 mm | In distribution |
| X064-0028-DL | Length 45 mm | In distribution |
| X022-0024 | Length 55 mm | In distribution |
| X022-0105 | Outer Diameter 8.25 mm | In distribution |
| X077-0700 | Length 35 mm | In distribution |
| X064-7530C | Outer Diameter 7.5 mm | In distribution |
| X022-0086-DL | Outer Diameter 5.5 mm | In distribution |
| N60001075 | Length 50 mm | In distribution |
| X022-0080-DL | Outer Diameter 4.75 mm | In distribution |
| X064-82540-DL | Outer Diameter 8.25 mm | In distribution |
| X022-0002 | Outer Diameter 4.75 mm | In distribution |
| X064-47555C | Outer Diameter 4.75 mm | In distribution |
| X022-0102 | Outer Diameter 7.5 mm | In distribution |
| X064-5545C | Length 45 mm | In distribution |
| X064-7555SD-DL | Length 55 mm | In distribution |
| X022-0005 | Outer Diameter 4.75 mm | In distribution |
| X077-0610 | Outer Diameter 5.5 mm | In distribution |
| X022-0114 | Length 80 mm | In distribution |
| X064-6530C-DL | Outer Diameter 6.5 mm | In distribution |
| X022-0103 | Length 55 mm | In distribution |
| X022-0088-DL | Length 40 mm | In distribution |
| X064-0102 | Length 50 mm | In distribution |
| X022-0028 | Outer Diameter 8.25 mm | In distribution |
| X064-47555 | Length 55 mm | In distribution |
| X064-6555SD-DL | Outer Diameter 6.5 mm | In distribution |
| N60000483 | In distribution | |
| X022-0109 | Length 55 mm | In distribution |
| X022-0027 | Length 40 mm | In distribution |
| X077-0420 | Length 500 mm | In distribution |
| X064-0004-DL | Length 45 mm | In distribution |
| X064-0080-DL | Outer Diameter 4.75 mm | In distribution |
| X022-0089-DL | Outer Diameter 5.5 mm | In distribution |
| X022-0032 | Length 65 mm | In distribution |
| X077-0507 | Length 70 mm | In distribution |
| X064-5550 | Length 50 mm | In distribution |
| X064-0014 | Outer Diameter 6.5 mm | In distribution |
| X064-0082-DL | Length 40 mm | In distribution |
| X022-0042 | In distribution | |
| X064-0008 | Length 35 mm | In distribution |
| X064-82545C-DL | Length 45 mm | In distribution |
| X064-0017-DL | Outer Diameter 6.5 mm | In distribution |
| X064-6530 | Length 30 mm | In distribution |
| X022-0150 | In distribution | |
| X064-0025-DL | Outer Diameter 8.25 mm | In distribution |
| X064-7555C | Length 55 mm | In distribution |
| X064-47535C | Length 35 mm | In distribution |
| X064-82555C | Length 55 mm | In distribution |
| X064-5555C-DL | Length 55 mm | In distribution |
| X064-6535C-DL | Length 35 mm | In distribution |
| X022-0092-DL | Length 30 mm | In distribution |
| X077-0406 | Length 65 mm | In distribution |
| N60001092 | Length 40 mm | In distribution |
| N60000481 | In distribution | |
| X077-0704 | Length 55 mm | In distribution |
| X022-5545SD-DL | Outer Diameter 5.5 mm | In distribution |
| X077-0504 | Outer Diameter 5.5 mm | In distribution |
| X064-0090 | Length 50 mm | In distribution |
| X064-0003-DL | Length 40 mm | In distribution |
| X022-6530SD | Length 30 mm | In distribution |
| X064-5550-DL | Outer Diameter 5.5 mm | In distribution |
| X022-0007 | Outer Diameter 5.5 mm | In distribution |
| X077-0619 | Length 160 mm | In distribution |
| X064-0087-DL | Length 35 mm | In distribution |
| X064-0101 | Length 45 mm | In distribution |
| X077-0408 | Length 75 mm | In distribution |
| X064-0091-DL | Length 55 mm | In distribution |
| X064-7530SD | Outer Diameter 7.5 mm | In distribution |
| X077-0606 | Length 65 mm | In distribution |
| X022-0301-CS | In distribution | |
| X022-7540SD-DL | Outer Diameter 7.5 mm | In distribution |
| X064-6540 | Outer Diameter 6.5 mm | In distribution |
| X022-0029 | Length 50 mm | In distribution |
| X077-0702 | Length 45 mm | In distribution |
| X064-82555 | Length 55 mm | In distribution |
| X077-0616 | Outer Diameter 5.5 mm | In distribution |
| X022-0195 | In distribution | |
| X064-7540SD-DL | Outer Diameter 7.5 mm | In distribution |
| X064-0009 | Length 40 mm | In distribution |
| X064-0022-DL | Outer Diameter 7.5 mm | In distribution |
| X064-6545-DL | Outer Diameter 6.5 mm | In distribution |
| X010-0154 | In distribution | |
| X064-6550C | Length 50 mm | In distribution |
| X064-82550C-DL | Outer Diameter 8.25 mm | In distribution |
| X064-0088 | Length 40 mm | In distribution |
| X064-6530C | Length 30 mm | In distribution |
| N60001081 | Outer Diameter 5.5 mm | In distribution |
| X077-0502 | Outer Diameter 5.5 mm | In distribution |
| X064-0023-DL | Length 50 mm | In distribution |
| X064-0104-DL | Outer Diameter 8.25 mm | In distribution |
| X077-0505 | Length 60 mm | In distribution |
| X022-0011 | Length 50 mm | In distribution |
| X010-0600 | In distribution | |
| X077-0401 | Length 40 mm | In distribution |
| N60001099 | Length 95 mm | In distribution |
| X022-0090-DL | Length 50 mm | In distribution |
| X077-0603 | Outer Diameter 5.5 mm | In distribution |
| X022-0098-DL | Outer Diameter 7.5 mm | In distribution |
| X064-0108-DL | Outer Diameter 8.25 mm | In distribution |
| X064-47530-DL | Outer Diameter 4.75 mm | In distribution |
| X077-0409 | Outer Diameter 5.5 mm | In distribution |
| X022-0210 | In distribution | |
| N60001078 | Outer Diameter 5.5 mm | In distribution |
| X022-0023 | Length 50 mm | In distribution |
| X077-0508 | Outer Diameter 5.5 mm | In distribution |
| X022-0094-DL | Outer Diameter 6.5 mm | In distribution |
| X077-0407 | Outer Diameter 5.5 mm | In distribution |
| X064-7550-DL | Outer Diameter 7.5 mm | In distribution |
| X064-0007 | Length 30 mm | In distribution |
| X064-0039 | In distribution | |
| X064-7530C-DL | Length 30 mm | In distribution |
| X022-0201 | In distribution | |
| X022-0086 | Length 30 mm | In distribution |
| X064-0006 | Outer Diameter 4.75 mm | In distribution |
| X064-5550SD-DL | Length 50 mm | In distribution |
| X064-82540C | Length 40 mm | In distribution |
| C022-0013 | In distribution | |
| X064-0015 | Outer Diameter 6.5 mm | In distribution |
| X077-0517 | Length 180 mm | In distribution |
| X064-6545SD-DL | Outer Diameter 6.5 mm | In distribution |
| X022-0100-DL | Outer Diameter 7.5 mm | In distribution |
| X077-0604 | Length 55 mm | In distribution |
| X064-5540SD-DL | Length 40 mm | In distribution |
| C022-0017-1 | In distribution | |
| X022-0106-DL | Outer Diameter 8.25 mm | In distribution |
| X077-0709 | Length 80 mm | In distribution |
| X064-5540C | Outer Diameter 5.5 mm | In distribution |
| X022-0081-DL | Length 35 mm | In distribution |
| X064-0012 | Outer Diameter 5.5 mm | In distribution |
| X064-6545C-DL | Outer Diameter 6.5 mm | In distribution |
| X022-0020 | Length 35 mm | In distribution |
| X022-0003 | Length 40 mm | In distribution |
| X077-0612 | Length 95 mm | In distribution |
| X077-0701 | Length 40 mm | In distribution |
| X022-0108 | Outer Diameter 8.25 mm | In distribution |
| X022-0110 | Outer Diameter 8.25 mm | In distribution |
| X064-47540 | Length 40 mm | In distribution |
| X064-47540C-DL | Length 40 mm | In distribution |
| X022-0082 | Length 40 mm | In distribution |
| X022-0169 | In distribution | |
| X077-0715 | Outer Diameter 5.5 mm | In distribution |
| X077-0518 | Length 200 mm | In distribution |
| X064-7555SD | Length 55 mm | In distribution |
| N60001073 | Length 35 mm | In distribution |
| X064-5530SD | Length 30 mm | In distribution |
| X064-0103-DL | Length 55 mm | In distribution |
| X064-7545C | Length 45 mm | In distribution |
| X077-0412 | Length 95 mm | In distribution |
| X077-0601 | Outer Diameter 5.5 mm | In distribution |
| X022-0087-DL | Length 35 mm | In distribution |
| X022-6535SD | Length 35 mm | In distribution |
| X064-0021-DL | Length 40 mm | In distribution |
| X064-0027-DL | Length 40 mm | In distribution |
| X022-0123 | In distribution | |
| X064-0021 | Length 40 mm | In distribution |
| X064-0026 | Length 35 mm | In distribution |
| X064-0106-DL | Length 40 mm | In distribution |
| X064-6535SD-DL | Length 35 mm | In distribution |
| N60001077 | Outer Diameter 5.5 mm | In distribution |
| X064-0019-DL | Outer Diameter 7.5 mm | In distribution |
| X022-5535SD | Length 35 mm | In distribution |
| X064-0086-DL | Length 30 mm | In distribution |
| N60001093 | Outer Diameter 5.5 mm | In distribution |
| N60001103 | Length 140 mm | In distribution |
| X022-0300 | In distribution | |
| X022-0006 | Outer Diameter 4.75 mm | In distribution |
| X064-6555 | Outer Diameter 6.5 mm | In distribution |
| X022-0015 | Outer Diameter 6.5 mm | In distribution |
| X022-7555SD | Outer Diameter 7.5 mm | In distribution |
| X064-0086 | Outer Diameter 5.5 mm | In distribution |
| X022-0104-DL | Outer Diameter 8.25 mm | In distribution |
| X064-7555C-DL | Length 55 mm | In distribution |
| X064-0018 | Outer Diameter 6.5 mm | In distribution |
| X064-6550SD-DL | Length 50 mm | In distribution |
| X022-0105-DL | Outer Diameter 8.25 mm | In distribution |
| X070-0012 | In distribution | |
| X064-5545SD | Outer Diameter 5.5 mm | In distribution |
| X022-0080 | Length 30 mm | In distribution |
| X064-7540SD | Length 40 mm | In distribution |
| X010-0166 | In distribution | |
| X064-5530C | Length 30 mm | In distribution |
| X022-6535SD-DL | Length 35 mm | In distribution |
| X064-0018-DL | Length 55 mm | In distribution |
| X064-7535-DL | Length 35 mm | In distribution |
| X064-0087 | Outer Diameter 5.5 mm | In distribution |
| X064-0084 | Length 50 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation
Recalls Naming This Product
4 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 |
|---|---|---|---|---|---|---|---|
| Xtant Medical Holdings, Inc. | 510(k) number | 2026-02-18 | Class II | Under Investigation by firm | Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is. | 2 units | |
| Xtant Medical Holdings, Inc. | 510(k) number | 2017-04-12 | Class II | Labeling mix-ups | The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium. | 97 units | 2017-08-16 |
| Xtant Medical Holdings, Inc. | 510(k) number | 2015-04-07 | Class II | Other | The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length. | 75 units | 2015-10-01 |
| Xtant Medical Holdings, Inc. | 510(k) number | 2015-03-11 | Class II | Nonconforming Material/Component | One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label. | 14 units | 2015-10-21 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-03-24 | Not classified | Process control | A defect cause was discovered following a customer complaint pertaining to a post operative dissociation of the Capless Li Screw construct. The screw assembly is made up of three parts; a cup which locks onto a 5.5mm rod, a yoke that cradl | 9,613 units | 2012-04-25 |
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.