CTL Amedica Navigation Instruments
Navigation Headless Driver, Threaded, T25, Non-Cannulated
5manufacturers in China registered for this device type
45catalogue numbers in this listing
1510(k) clearance
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 | CTL Medical Corporation, United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K213491 |
| Record published | 2025-06-03 |
| Record revised | 2026-04-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 109.7838 | In distribution | |
| 109.7753 | In distribution | |
| 109.7767 | In distribution | |
| 109.7534 | In distribution | |
| 109.7250 | In distribution | |
| 109.7837 | In distribution | |
| 109.7752 | In distribution | |
| 109.7830 | In distribution | |
| 109.7765 | In distribution | |
| 109.7531 | In distribution | |
| 109.7251 | In distribution | |
| 109.7776 | In distribution | |
| 109.7230 | In distribution | |
| 109.7833 | In distribution | |
| 109.8701 | In distribution | |
| 109.7733 | In distribution | |
| 109.7732 | In distribution | |
| 109.7530 | In distribution | |
| 109.7835 | In distribution | |
| 109.7301 | In distribution | |
| 109.7736 | In distribution | |
| 109.7839 | In distribution | |
| 109.7232 | In distribution | |
| 109.7836 | In distribution | |
| 109.7751 | In distribution | |
| 109.7634 | In distribution | |
| 109.7633 | In distribution | |
| 109.7630 | In distribution | |
| 109.7786 | In distribution | |
| 109.7631 | In distribution | |
| 109.7831 | In distribution | |
| 109.7234 | In distribution | |
| 109.7210 | In distribution | |
| 109.7233 | In distribution | |
| 109.7734 | In distribution | |
| 109.7735 | In distribution | |
| 109.7532 | In distribution | |
| 109.7632 | In distribution | |
| 109.7550 | In distribution | |
| 109.7231 | In distribution | |
| 109.7834 | In distribution | |
| 109.7731 | In distribution | |
| 109.7754 | In distribution | |
| 109.7832 | In distribution | |
| 109.7533 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213491 | 2022-05-12 |
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.