Overwatch
Overwatch® Iliac N Driver Cannulated
5manufacturers in China registered for this device type
34catalogue 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 | Spinal Elements, Inc., United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-05-18 |
| Record revised | 2023-05-03 (version 3) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 108-158-01C | In distribution | |
| 108-454-C105 | In distribution | |
| 108-154-095 | In distribution | |
| 108-154-45 | In distribution | |
| 108-154-065 | In distribution | |
| 108-154-055 | In distribution | |
| 108-454-105 | In distribution | |
| 108-454-095 | In distribution | |
| 108-157-01C | In distribution | |
| 108-154-C45 | In distribution | |
| 108-154-C105 | In distribution | |
| 108-454-055 | In distribution | |
| 108-155-C065 | In distribution | |
| 108-154-C095 | In distribution | |
| 108-154-075 | In distribution | |
| 108-155-C085 | In distribution | |
| 108-154-085 | In distribution | |
| 108-157-01 | In distribution | |
| 108-457-01 | In distribution | |
| 108-454-085 | In distribution | |
| 108-155-C075 | In distribution | |
| 108-154-C055 | In distribution | |
| 108-154-C075 | In distribution | |
| 108-154-105 | In distribution | |
| 108-457-01C | In distribution | |
| 108-454-075 | In distribution | |
| 108-155-C105 | In distribution | |
| 108-454-C095 | In distribution | |
| 108-155-C055 | In distribution | |
| 108-154-C065 | In distribution | |
| 108-454-065 | In distribution | |
| 108-155-C095 | In distribution | |
| 108-154-C085 | In distribution | |
| 108-154-40 | 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 |
|---|---|
| K190881 | 2019-12-19 |
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.