Ultra-Drive® Tool
56 MM X 85 Degree Acetabular Gouge
1manufacturer
40catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | JXE |
| Device type | Device, Nerve Conduction Velocity Measurement |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1550 |
| 510(k) | K031280 |
| Record published | 2023-09-07 |
| Record revised | 2025-05-30 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 423840 | 180 mm | In distribution |
| 423864 | 5 mm | In distribution |
| 423922 | In distribution | |
| 423894 | In distribution | |
| 423872 | In distribution | |
| 423890 | In distribution | |
| 423881 | 9.5MM | In distribution |
| 423868 | In distribution | |
| 423830 | 7° 180 mm | In distribution |
| 423922 | 5 mm | In distribution |
| 423923 | 7 mm | In distribution |
| 423873 | 11 mm | In distribution |
| 423892 | 6 mm Long | In distribution |
| 423892 | In distribution | |
| 423923 | 7MM | In distribution |
| 423840 | In distribution | |
| 423883 | 6.5MM | In distribution |
| 423883 | 6.5 mm | In distribution |
| 423890 | 6 mm Long | In distribution |
| 423921 | In distribution | |
| 423842 | In distribution | |
| 423873 | In distribution | |
| 423868 | 6 mm | In distribution |
| 423830 | In distribution | |
| 423856 | In distribution | |
| 423925 | In distribution | |
| 423871 | In distribution | |
| 423924 | 9.5 mm | In distribution |
| 423924 | In distribution | |
| 423859 | In distribution | |
| 423828 | 5° 180 mm | In distribution |
| 423864 | In distribution | |
| 423838 | In distribution | |
| 423826 | In distribution | |
| 423836 | In distribution | |
| 423880 | In distribution | |
| 423828 | In distribution | |
| 423876 | In distribution | |
| 423926 | In distribution | |
| 423894 | 7 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Advance | Neurometrix, Inc. | 18 |
| DPNCheck | Impulse Technology LLC | 7 |
| Chalgren | Chalgren Enterprises, Inc. | 5 |
| Rhythmlink® | Rhythmlink International, LLC | 4 |
| Ultra-Drive | Biomet Orthopedics | 3 |
| Cadwell Guardian | Cadwell Industries, Inc. | 2 |
| NC-stat DPNCheck | Neurometrix, Inc. | 2 |
| NeMus 1 | EB Neuro SPA | 2 |
| Sierra Wave | Cadwell Industries, Inc. | 2 |
| Cascade | Cadwell Industries, Inc. | 2 |
| NeMus PC Peripheral | EB Neuro SPA | 1 |
| Focus | Neurosoft, OOO | 1 |
Showing 12 of 32. All products under Device, Nerve Conduction Velocity Measurement
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2019-06-04 | Class II | Under Investigation by firm | The products do not have sufficient data to support the labeled shelf life of 10 years. | 8478 total | 2021-07-21 |
| Biomet, Inc. | 510(k) number | 2019-06-04 | Class II | Under Investigation by firm | The products do not have sufficient data to support the labeled shelf life of 10 years. | 8478 total | 2021-07-21 |
| Biomet, Inc. | 510(k) number | 2012-04-18 | Not classified | Process design | Incorrect product picture label was on the product box. | 30 units | 2013-04-18 |
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.