Velys
Velys Spine Skull Frame Adjustment Wrench
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 | Medos International Sàrl, Switzerland |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Record published | 2025-03-28 |
| Record revised | 2026-03-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 451611037 | In distribution | |
| 451611041 | In distribution | |
| 451611038 | In distribution | |
| 451611046 | In distribution | |
| 451611031 | In distribution | |
| 451611001 | In distribution | |
| 451611054 | In distribution | |
| 451611056 | In distribution | |
| 451611036 | In distribution | |
| 451611032 | In distribution | |
| 451611049 | In distribution | |
| 451611048 | In distribution | |
| 451611063 | In distribution | |
| 451611039 | In distribution | |
| 451611021 | In distribution | |
| 451611022 | In distribution | |
| 451611042 | In distribution | |
| 451611043 | In distribution | |
| 451611045 | In distribution | |
| 451611053 | In distribution | |
| 451611055 | In distribution | |
| 451611023 | In distribution | |
| 451611057 | In distribution | |
| 451611002 | In distribution | |
| 451611061 | In distribution | |
| 451611058 | In distribution | |
| 451611050 | In distribution | |
| 451611047 | In distribution | |
| 451611030 | In distribution | |
| 451611035 | In distribution | |
| 451611000 | In distribution | |
| 451611044 | In distribution | |
| 451611062 | In distribution | |
| 451611040 | 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 |
|---|---|
| K231527 | 2023-09-29 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medos International Sarl | UDI-DI | 2026-07-23 | Class II | Under Investigation by firm | Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning. | 29 stations |
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.