Cortera
Driver, Nav, Poly, Shaft, Cann, Jcb
5manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Guangdong (1). 3 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Surgalign Spine Technologies, United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| 510(k) | K200095 |
| Record published | 2023-06-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1505-800604 | In distribution | |
| 1505-812450 | In distribution | |
| 1505-820550 | In distribution | |
| 1505-821250 | In distribution | |
| 1505-810850 | In distribution | |
| 1505-810600 | In distribution | |
| 1505-812050 | In distribution | |
| 1505-850950 | In distribution | |
| 1505-812700 | In distribution | |
| 1505-850400 | In distribution | |
| 1505-850650 | In distribution | |
| 1505-820800 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Valence Robotic Navigation System | Alphatec Spine, Inc. | 813 |
| Olympic | Astura Medical | 684 |
| Excelsius GPS | Globus Medical, Inc. | 383 |
| Orthopedic Stereotaxic Instrument | Medtronic Navigation, Inc. | 356 |
| Masada | Astura Medical | 335 |
| Excelsiusgps | Globus Medical, Inc. | 297 |
| Invictus | Alphatec Spine, Inc. | 235 |
| OrthAlign Plus | OrthAlign, Inc. | 210 |
| Arvis ® | Kico Knee Innovation Company | 174 |
| OMNIBotics | Omni Life Science, Inc. | 150 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 137 |
| Navigation Instruments | VB Spine LLC | 135 |
Showing 12 of 1,127. All products under Orthopedic Stereotaxic Instrument
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 |
|---|---|---|---|---|---|---|---|
| Pioneer Surgical Technology, Inc. | 510(k) number | 2020-09-24 | Class II | Device Design | The Streamline Navigation System taps have experienced binding with other devices. | 420 units | 2024-09-16 |
| Pioneer Surgical Technology, Inc. | 510(k) number | 2020-09-24 | Class II | Device Design | The Streamline Navigation System taps have experienced binding with other devices. | 420 | 2024-09-16 |
| Pioneer Surgical Technology, Inc. | 510(k) number | 2020-09-24 | Class II | Device Design | System does not include a drill guide. | 76 units | |
| Pioneer Surgical Technology, Inc. | 510(k) number | 2020-09-11 | Class II | Device Design | The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve. | 143 units | 2024-05-23 |
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.