Velocity Alpha ™
Velocity Alpha is an electric surgical drill system for cutting, drilling, sawing and shaping bone, soft tissue and bone-replacement materials in neurosurgery and spinal surgery. An…
Velocity Alpha is an electric surgical drill system for cutting, drilling, sawing and shaping bone, soft tissue and bone-replacement materials in neurosurgery and spinal surgery. An AC-powered control unit drives a motor handpiece connected to a selected attachment.
The family includes straight and angled nosepieces, craniotome attachments, speed reducers and sawing attachments. Wired or Bluetooth foot controls operate the system; the filed wireless foot-control pack is one control option within this broader component family.
Listed Item
foot control, electric, Bluetooth™ wireless, incl. Bluetooth™ dongle VAFCD and bar for foot switch VMME-FS-H
Motor and Irrigation Controls
Motor speed is variable from 1,000 to 80,000 rpm, with left or right rotation selectable. The foot control provides motor operation, program selection, rotation direction and pump controls. An optional irrigation pump supplies fluid through sterile tubing.
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Adeor Medical AG, Germany |
|---|---|
| FDA product code | HBE |
| Device type | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4310 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K191479 |
| Record published | 2021-06-10 |
| Record revised | 2023-05-26 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| angled nosepiece XL | In distribution | |
| minimally invasive attachment 120 mm straight | In distribution | |
| minimally invasive attachment 90 mm straight | In distribution | |
| Craniotome attachment | In distribution | |
| minimally invasive attachment 180 mm straight | In distribution | |
| angled nosepiece medium | In distribution | |
| angled nosepiece XXXL, working length 220 mm | In distribution | |
| control unit, touchscreen, incl. irrigation pump, 220 V | In distribution | |
| Irrigation adapter XXL | In distribution | |
| minimally invasive attachment 120 mm curved | In distribution | |
| angled nosepiece short | In distribution | |
| base unit for VMN-T attachments | In distribution | |
| control unit, touchscreen, incl. irrigation pump, 110 V | In distribution | |
| Steri-Tray made from plastic, custom made for motor systems, custom made | In distribution | |
| foot control, electric, Bluetooth™ wireless, incl. Bluetooth™ dongle VAFCD | In distribution | |
| Steri-Tray made from plastic, custom made for MR conditional system | In distribution | |
| Irrigation adapter short | In distribution | |
| Duraguard rotatable, short | In distribution | |
| minimally invasive attachment 150 mm straight | In distribution | |
| Duraguard fixed, short | In distribution | |
| Trepan adapter with hudson fitting, low speed | In distribution | |
| Irrigation adapter medium | In distribution | |
| straight nosepiece extra short | In distribution | |
| angled nosepiece long | In distribution | |
| Duraguard rotatable, medium | In distribution | |
| Irrigation adapter long | In distribution | |
| Oscillating saw attachment | In distribution | |
| Reciprocating saw attachment | In distribution | |
| receiver for VAFCBT Bluetooth™ foot control, CAN dongle | In distribution | |
| foot control, electric, incl. 3 m cable and bar for foot switch VMME-FS-H | In distribution | |
| Irrigation adapter XL | In distribution | |
| minimally invasive attachment 150 mm curved | In distribution | |
| Duraguard rotatable, long | In distribution | |
| Irrigation adapter XXXL | In distribution | |
| angled nosepiece XXL, working length 170 mm | In distribution | |
| Craniotome head for VMN-C1 | In distribution | |
| Sagittal saw attachment | In distribution | |
| Irrigation adapter XS | In distribution | |
| Duraguard fixed, medium | In distribution | |
| Duraguard fixed, long | In distribution | |
| straight nosepiece short | In distribution | |
| straight nosepiece long | In distribution | |
| highspeed motor, electric, 80.000 rpm, incl. 3.5 m cable | In distribution | |
| Storage and Sterilization tray, stainless steel, Velocity Alpha | In distribution | |
| straight nosepiece medium | In distribution | |
| minimally invasive attachment 90 mm curved | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Midas REX MR8 | Medtronic Powered Surgical Solutions | 1,006 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Stryker GmbH | 948 |
| Elan 4 | Aesculap AG | 529 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Synthes Gmbh | 514 |
| Zethon | Zethon Ltd | 237 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Stryker Leibinger Gmbh & Co. KG | 220 |
| Midas Rex® | Medtronic Powered Surgical Solutions | 167 |
| HiCUT Burs | Adeor Medical AG | 90 |
| Phasor | Phasor Health, LLC | 80 |
| Traumaone System | Biomet Microfixation | 62 |
| Midas REX Microsaws | Medtronic Powered Surgical Solutions | 60 |
| Mids REX MR8 | Medtronic Powered Surgical Solutions | 59 |
Showing 12 of 269. All products under Drills, Burrs, Trephines & Accessories (Simple, Powered)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191479 | 2021-04-11 |
| K130755 | 2014-06-27 |
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.