X90 Pedicle Screw System
Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 55
13manufacturers in China registered for this device type
208catalogue numbers in this listing
1recall
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 | Xtant Medical Holdings, Inc., United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K052847 |
| Record published | 2015-09-28 |
| Record revised | 2025-07-02 (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 25 to 300 mm; outer diameter 4.75 to 8.25 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N60000601 | Outer Diameter 4.75 mm | In distribution |
| N60000618-DL | Outer Diameter 7.5 mm | In distribution |
| N60000339 | Outer Diameter 7.5 mm | In distribution |
| N60000338-DL | Outer Diameter 7.5 mm | In distribution |
| N60000615 | Length 45 mm | In distribution |
| N60001038-DL | Outer Diameter 4.75 mm | In distribution |
| N60000342 | Length 35 mm | In distribution |
| N60000328-DL | Length 45 mm | In distribution |
| N60000623 | Outer Diameter 7.5 mm | In distribution |
| N60000338 | Length 45 mm | In distribution |
| N60000413 | In distribution | |
| N60000612 | Length 30 mm | In distribution |
| N60000601-DL | Length 35 mm | In distribution |
| N60000616-DL | Outer Diameter 6.5 mm | In distribution |
| N60001552 | In distribution | |
| N60000613 | Outer Diameter 6.5 mm | In distribution |
| N60000408 | Length 33 mm | In distribution |
| N60001088 | Length 85 mm | In distribution |
| N60001578 | In distribution | |
| N60000319-DL | Outer Diameter 5.5 mm | In distribution |
| N60000600 | Outer Diameter 4.75 mm | In distribution |
| N60000614-DL | Length 40 mm | In distribution |
| N60001540 | In distribution | |
| N60000605 | Outer Diameter 4.75 mm | In distribution |
| N60000326 | Length 35 mm | In distribution |
| N605555SD-DL | Outer Diameter 5.5 mm | In distribution |
| N605555SD | Outer Diameter 5.5 mm | In distribution |
| N60002103 | In distribution | |
| N60000405 | Length 27 mm | In distribution |
| N607550SD-DL | Length 50 mm | In distribution |
| N606555SD-DL | Outer Diameter 6.5 mm | In distribution |
| N60001085 | Length 55 mm | In distribution |
| N605540SD | Outer Diameter 5.5 mm | In distribution |
| N60000618 | Outer Diameter 7.5 mm | In distribution |
| N60000617-DL | Length 55 mm | In distribution |
| N60000351-DL | Length 50 mm | In distribution |
| N60001084 | Length 45 mm | In distribution |
| N606535SD | Length 35 mm | In distribution |
| N60001036 | Length 30 mm | In distribution |
| N60000477 | In distribution | |
| N60000341 | Length 30 mm | In distribution |
| N60000602-DL | Outer Diameter 4.75 mm | In distribution |
| N60000629-DL | Outer Diameter 8.25 mm | In distribution |
| N60000515 | In distribution | |
| N60000624 | Outer Diameter 8.25 mm | In distribution |
| N60001040-DL | Outer Diameter 4.75 mm | In distribution |
| N60000622 | Outer Diameter 7.5 mm | In distribution |
| CN60-0021 | In distribution | |
| N60000615-DL | Length 45 mm | In distribution |
| N606545SD-DL | Outer Diameter 6.5 mm | In distribution |
| N605550SD | Length 50 mm | In distribution |
| N605545SD | Length 45 mm | In distribution |
| N607540SD | Outer Diameter 7.5 mm | In distribution |
| N60001036-DL | Length 30 mm | In distribution |
| N606545SD | Length 45 mm | In distribution |
| N60000336-DL | Outer Diameter 7.5 mm | In distribution |
| N60000330-DL | Length 55 mm | In distribution |
| N60000610 | Outer Diameter 5.5 mm | In distribution |
| N60000350 | Outer Diameter 8.25 mm | In distribution |
| N607550SD | Outer Diameter 7.5 mm | In distribution |
| N60002102 | In distribution | |
| N60000341-DL | Outer Diameter 8.25 mm | In distribution |
| N607540SD-DL | Length 40 mm | In distribution |
| N60000317 | Outer Diameter 5.5 mm | In distribution |
| N60000340-DL | Length 55 mm | In distribution |
| N607535SD | Outer Diameter 7.5 mm | In distribution |
| N60001086 | Length 65 mm | In distribution |
| N60001577 | In distribution | |
| N60000918 | Length 120 mm | In distribution |
| N60001082 | Length 35 mm | In distribution |
| N60000606 | Outer Diameter 5.5 mm | In distribution |
| N60000619-DL | Length 35 mm | In distribution |
| N60001039 | Length 45 mm | In distribution |
| N606540SD-DL | Outer Diameter 6.5 mm | In distribution |
| N60001038 | Length 40 mm | In distribution |
| N60000315 | Outer Diameter 5.5 mm | In distribution |
| N60000414 | In distribution | |
| N60000623-DL | Outer Diameter 7.5 mm | In distribution |
| N60000914 | Length 50 mm | In distribution |
| N605530SD-DL | Outer Diameter 5.5 mm | In distribution |
| CN60-0025 | In distribution | |
| N607530SD | Outer Diameter 7.5 mm | In distribution |
| N60001041-DL | Length 55 mm | In distribution |
| N60000917 | Length 100 mm | In distribution |
| N60000407 | Length 31 mm | In distribution |
| N60000320-DL | Length 55 mm | In distribution |
| N60000922 | Length 200 mm | In distribution |
| N605530SD | Outer Diameter 5.5 mm | In distribution |
| N60000606-DL | Outer Diameter 5.5 mm | In distribution |
| N60000326-DL | Length 35 mm | In distribution |
| N606530SD-DL | Length 30 mm | In distribution |
| N60000343 | Outer Diameter 8.25 mm | In distribution |
| N60000352-DL | Length 55 mm | In distribution |
| N60000318 | Outer Diameter 5.5 mm | In distribution |
| N607535SD-DL | Length 35 mm | In distribution |
| N60000602 | Length 40 mm | In distribution |
| N60000609-DL | Outer Diameter 5.5 mm | In distribution |
| N60000478 | In distribution | |
| N60000330 | Outer Diameter 6.5 mm | In distribution |
| N60001037-DL | Length 35 mm | In distribution |
| N60000626 | Outer Diameter 8.25 mm | In distribution |
| N60000604-DL | Length 50 mm | In distribution |
| N60000479 | In distribution | |
| N60000316 | Length 35 mm | In distribution |
| N60000351 | Outer Diameter 8.25 mm | In distribution |
| N60000335-DL | Length 30 mm | In distribution |
| N607555SD | Length 55 mm | In distribution |
| N60000607-DL | Outer Diameter 5.5 mm | In distribution |
| N60000628-DL | Length 50 mm | In distribution |
| N60000340 | Outer Diameter 7.5 mm | In distribution |
| N60000622-DL | Outer Diameter 7.5 mm | In distribution |
| N60000625-DL | Length 35 mm | In distribution |
| N60000920 | Length 160 mm | In distribution |
| N60000627 | Outer Diameter 8.25 mm | In distribution |
| N60000315-DL | Outer Diameter 5.5 mm | In distribution |
| N605535SD-DL | Length 35 mm | In distribution |
| N607545SD | Outer Diameter 7.5 mm | In distribution |
| N60000329-DL | Outer Diameter 6.5 mm | In distribution |
| N60000319 | Outer Diameter 5.5 mm | In distribution |
| N60000608-DL | Outer Diameter 5.5 mm | In distribution |
| N60000921 | Length 180 mm | In distribution |
| N60000603-DL | Outer Diameter 4.75 mm | In distribution |
| N60000316-DL | Outer Diameter 5.5 mm | In distribution |
| N60000325-DL | Outer Diameter 6.5 mm | In distribution |
| N60000604 | Outer Diameter 4.75 mm | In distribution |
| N60000320 | Outer Diameter 5.5 mm | In distribution |
| N606555SD | Length 55 mm | In distribution |
| N60000350-DL | Length 45 mm | In distribution |
| N605545SD-DL | Length 45 mm | In distribution |
| N60000616 | Length 50 mm | In distribution |
| N60000915 | Length 60 mm | In distribution |
| N60000339-DL | Outer Diameter 7.5 mm | In distribution |
| N60000609 | Outer Diameter 5.5 mm | In distribution |
| N60000411 | In distribution | |
| N60000327 | Outer Diameter 6.5 mm | In distribution |
| N60000610-DL | Length 50 mm | In distribution |
| N606530SD | Outer Diameter 6.5 mm | In distribution |
| N60000342-DL | Outer Diameter 8.25 mm | In distribution |
| N607555SD-DL | Length 55 mm | In distribution |
| N60000410 | In distribution | |
| N60000621 | Length 45 mm | In distribution |
| N60000328 | Outer Diameter 6.5 mm | In distribution |
| N606540SD | Outer Diameter 6.5 mm | In distribution |
| N60000275 | In distribution | |
| N60000336 | Outer Diameter 7.5 mm | In distribution |
| N60000605-DL | Length 55 mm | In distribution |
| N60000322 | In distribution | |
| N60000626-DL | Outer Diameter 8.25 mm | In distribution |
| N60000611-DL | Outer Diameter 5.5 mm | In distribution |
| N60000325 | Length 30 mm | In distribution |
| N60000406 | Length 29 mm | In distribution |
| N60001040 | Outer Diameter 4.75 mm | In distribution |
| N60000628 | Outer Diameter 8.25 mm | In distribution |
| N60000603 | Outer Diameter 4.75 mm | In distribution |
| N60001041 | Length 55 mm | In distribution |
| N60000352 | Outer Diameter 8.25 mm | In distribution |
| N606550SD | Length 50 mm | In distribution |
| N60000607 | Outer Diameter 5.5 mm | In distribution |
| N60000404 | Length 25 mm | In distribution |
| N60000337 | Length 40 mm | In distribution |
| N60001610 | In distribution | |
| N60000624-DL | Length 30 mm | In distribution |
| N60000629 | Length 55 mm | In distribution |
| N60000327-DL | Length 40 mm | In distribution |
| N60001083 | Length 40 mm | In distribution |
| N60000923 | Length 300 mm | In distribution |
| N60000329 | Outer Diameter 6.5 mm | In distribution |
| N60000317-DL | Length 40 mm | In distribution |
| N60000919 | Length 140 mm | In distribution |
| N60000318-DL | Length 45 mm | In distribution |
| N606535SD-DL | Outer Diameter 6.5 mm | In distribution |
| N60001087 | Length 75 mm | In distribution |
| N60000337-DL | Outer Diameter 7.5 mm | In distribution |
| N60000625 | Length 35 mm | In distribution |
| N60001550 | In distribution | |
| N60002104 | In distribution | |
| N605535SD | Outer Diameter 5.5 mm | In distribution |
| CN60-0021-9 | In distribution | |
| N60002201 | In distribution | |
| N60001530 | In distribution | |
| N60000612-DL | Length 30 mm | In distribution |
| N60000613-DL | Outer Diameter 6.5 mm | In distribution |
| N60001090 | Length 95 mm | In distribution |
| N60001089 | Length 90 mm | In distribution |
| N60000343-DL | Length 40 mm | In distribution |
| N60000627-DL | Outer Diameter 8.25 mm | In distribution |
| N607530SD-DL | Outer Diameter 7.5 mm | In distribution |
| N60000600-DL | Length 30 mm | In distribution |
| N60000620-DL | Length 40 mm | In distribution |
| N605550SD-DL | Length 50 mm | In distribution |
| N60000409 | Length 35 mm | In distribution |
| N60000617 | Outer Diameter 6.5 mm | In distribution |
| N60000335 | Outer Diameter 7.5 mm | In distribution |
| N605540SD-DL | Outer Diameter 5.5 mm | In distribution |
| N60000608 | Length 40 mm | In distribution |
| N60000611 | Length 55 mm | In distribution |
| N60000497 | In distribution | |
| N60000614 | Outer Diameter 6.5 mm | In distribution |
| N606550SD-DL | Length 50 mm | In distribution |
| N60000916 | Length 80 mm | In distribution |
| N60000415 | In distribution | |
| N60000620 | Outer Diameter 7.5 mm | In distribution |
| N60001037 | Outer Diameter 4.75 mm | In distribution |
| N60001039-DL | Outer Diameter 4.75 mm | In distribution |
| N60000621-DL | Outer Diameter 7.5 mm | In distribution |
| N607545SD-DL | Length 45 mm | In distribution |
| N60000619 | Length 35 mm | In distribution |
| N60000412 | 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
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 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 |
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.