Cortera
The Cortera Spinal Fixation System is a posterior, non-cervical system for stabilizing spinal segments as an adjunct to fusion. The FDA summary identifies screws, rods, locking set screws…
The Cortera Spinal Fixation System is a posterior, non-cervical system for stabilizing spinal segments as an adjunct to fusion. The FDA summary identifies screws, rods, locking set screws and manual surgical instruments for open or minimally invasive approaches.
Its stated scope includes thoracic, lumbar and sacral spine. The filing describes use with autograft or allograft and separately identifies skeletally mature and pediatric indications. Pediatric pedicle-screw fixation is limited to a posterior approach.
Listed Item
Screw, Poly, MIS, Cann Iliac, 10.5×60
Implants and Rods
Screws and set screws are titanium alloy, while rods may be titanium or cobalt-chromium alloy. Streamline Cross Connectors are compatible with 5.5 mm Cortera rod systems and retain their separate cleared trade name.
15manufacturers in China registered for this device type
704catalogue 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 | Surgalign Spine Technologies, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K221403 |
| Record published | 2023-01-06 |
| Record revised | 2025-07-02 (version 3) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 150150-45120 | In distribution | |
| 150100-60120 | In distribution | |
| 150103-70065 | In distribution | |
| 150100-10115 | In distribution | |
| 150103-75075 | In distribution | |
| 150150-65120 | In distribution | |
| 150100-95110 | In distribution | |
| 150100-40080 | In distribution | |
| 150100-50115 | In distribution | |
| 150100-85085 | In distribution | |
| 150103-55115 | In distribution | |
| 150103-50105 | In distribution | |
| 150152-50115 | In distribution | |
| 150103-90080 | In distribution | |
| 150100-50080 | In distribution | |
| 150150-50105 | In distribution | |
| 150150-10085 | In distribution | |
| 150152-90120 | In distribution | |
| 150150-70105 | In distribution | |
| 150103-75115 | In distribution | |
| 150100-25105 | In distribution | |
| 150150-20090 | In distribution | |
| 150152-90090 | In distribution | |
| 150100-40090 | In distribution | |
| 150100-55085 | In distribution | |
| 150152-70070 | In distribution | |
| 150100-65065 | In distribution | |
| 150100-85075 | In distribution | |
| 150150-65085 | In distribution | |
| 150150-10075 | In distribution | |
| 150150-20075 | In distribution | |
| 150100-20115 | In distribution | |
| 150150-90120 | In distribution | |
| 150150-65065 | In distribution | |
| 150150-90095 | In distribution | |
| 150100-10095 | In distribution | |
| 150103-50095 | In distribution | |
| 150152-65080 | In distribution | |
| 150152-70090 | In distribution | |
| 150150-60095 | In distribution | |
| 150150-15095 | In distribution | |
| 150152-80110 | In distribution | |
| 150104-75060 | In distribution | |
| 150103-75095 | In distribution | |
| 150150-60110 | In distribution | |
| 150150-45085 | In distribution | |
| 150100-45115 | In distribution | |
| 150152-95085 | In distribution | |
| 150150-80105 | In distribution | |
| 150100-40100 | In distribution | |
| 150150-60100 | In distribution | |
| 150150-25080 | In distribution | |
| 150100-70110 | In distribution | |
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| 150100-90120 | In distribution | |
| 150100-80085 | In distribution | |
| 150150-95105 | In distribution | |
| 150100-00105 | In distribution | |
| 150100-90115 | In distribution | |
| 150100-55065 | In distribution | |
| 150100-20100 | In distribution | |
| 150150-90105 | In distribution | |
| 150150-50075 | In distribution | |
| 150150-15090 | In distribution | |
| 150150-50100 | In distribution | |
| 150103-60085 | In distribution | |
| 150150-50090 | In distribution | |
| 150150-60105 | In distribution | |
| 150100-25110 | In distribution | |
| 150100-20065 | In distribution | |
| 150103-80105 | In distribution | |
| 150152-50110 | In distribution | |
| 150103-55105 | In distribution | |
| 150100-60075 | In distribution | |
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| 150150-15120 | In distribution | |
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| 150103-75065 | In distribution | |
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| 150100-55100 | In distribution | |
| 150103-75080 | In distribution | |
| 150150-70110 | In distribution | |
| 150103-45115 | In distribution | |
| 150103-85105 | In distribution | |
| 150152-70095 | In distribution | |
| 150152-50095 | In distribution | |
| 150152-65095 | In distribution | |
| 150150-60075 | In distribution | |
| 150100-00090 | In distribution | |
| 150100-80065 | In distribution | |
| 150103-85065 | In distribution | |
| 150100-65085 | In distribution | |
| 150100-40095 | In distribution | |
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| 150100-40070 | In distribution | |
| 150103-80065 | In distribution | |
| 150152-90105 | In distribution | |
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| 150100-70120 | In distribution | |
| 150150-55085 | In distribution | |
| 150103-65075 | In distribution | |
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| 150103-70090 | In distribution | |
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| 150152-65110 | In distribution | |
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| 150100-75110 | In distribution | |
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| 150150-05110 | In distribution | |
| 150150-45080 | In distribution | |
| 150103-95070 | In distribution | |
| 150150-25100 | In distribution | |
| 150150-95080 | In distribution | |
| 150152-75115 | In distribution | |
| 150150-95075 | In distribution | |
| 150104-65060 | In distribution | |
| 150150-75065 | In distribution | |
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| 150150-55075 | In distribution | |
| 150150-75120 | In distribution | |
| 150100-80115 | In distribution | |
| 150100-55110 | In distribution | |
| 150150-15115 | In distribution | |
| 150103-95105 | In distribution | |
| 150100-60080 | In distribution | |
| 150150-55090 | In distribution | |
| 150103-65080 | In distribution | |
| 150150-10065 | In distribution | |
| 150100-15095 | In distribution | |
| 150100-50075 | In distribution | |
| 150152-85065 | In distribution | |
| 150150-15110 | In distribution | |
| 150100-50105 | In distribution | |
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| 150152-80080 | In distribution | |
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Showing 250 of 300 catalogue numbers.
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 |
|---|---|
| K221403 | 2022-08-19 |
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|
| Xtant Medical Holdings, Inc. | 510(k) number | 2024-08-21 | Class II | Process change control | Spinal fixation system implant screws marked “DNI” are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or p | 330 |
| Xtant Medical Holdings, Inc. | 510(k) number | 2023-11-28 | Class II | Process control | Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if | 6 |
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.