Response Navigation
RESPONSE Navigation Instruments are reusable taps, probes and drivers for preparing and placing RESPONSE spinal pedicle screws. They work with the specified Medtronic StealthStation…
RESPONSE Navigation Instruments are reusable taps, probes and drivers for preparing and placing RESPONSE spinal pedicle screws. They work with the specified Medtronic StealthStation navigation system during open procedures.
The tools are stainless steel. Taps span diameters from 3 to 8 mm, and the instrument interfaces match the RESPONSE spine implants.
Listed Item
5.5/6.0 Cannulated Reduction Pedicle Screw Driver Navigation
Navigation Compatibility
The instruments are designed for RESPONSE 4.5/5.0 and 5.5/6.0 systems and the specified StealthStation S8 hardware and software. Navigation references the vertebrae to CT, MR, fluoroscopic or digitized anatomical data. These are surgical tools rather than implanted fixation components.
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 | Orthopediatrics, Corp, 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) | K203573 |
| Record published | 2021-02-24 |
| Record revised | 2025-07-02 (version 4) |
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 |
|---|---|---|
| 01-1800-3040 | In distribution | |
| 01-1800-1050 | In distribution | |
| 01-1800-1030 | In distribution | |
| 01-1800-3050 | In distribution | |
| 01-1800-2080 | In distribution | |
| 01-1800-1035 | In distribution | |
| 01-1800-6037 | In distribution | |
| 01-1800-6038 | In distribution | |
| 01-1800-6043 | In distribution | |
| 01-1800-6036 | In distribution | |
| 01-1800-1045 | In distribution | |
| 01-1800-3045 | In distribution | |
| 01-1800-3055 | In distribution | |
| 01-1800-6041 | In distribution | |
| 01-1800-1040 | In distribution | |
| 01-1800-6042 | In distribution | |
| 01-1800-3060 | In distribution | |
| 01-1800-2070 | In distribution | |
| 01-1800-3035 | In distribution | |
| 01-1800-6044 | In distribution | |
| 01-1800-1060 | In distribution | |
| 01-1800-1055 | In distribution | |
| 01-1800-2060 | In distribution | |
| 01-1800-6040 | In distribution | |
| 01-1800-6035 | In distribution | |
| 01-1800-6022 | In distribution | |
| 01-1800-3030 | In distribution | |
| 01-1800-6021 | In distribution | |
| 01-1800-2055 | 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 |
|---|---|
| K203573 | 2021-02-04 |
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.