Ultra-Drive® Tool
11 catalogue numbers from 423876, listed by Biomet Orthopedics, United States, under Instrument, Surgical, Sonic And Accessory/Attachment. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
11catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Beijing (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Shenzhen Perfect Idea Technology Limited | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Smtp Medical Co., Ltd. | Daxing District | Beijing | Manufacturer | 2 |
| Huaan Hengyi (Beijing) Medical Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 2 |
| Shenzhen Codyson Electrical Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | JDX |
| Device type | Instrument, Surgical, Sonic And Accessory/Attachment |
| Device class | Class 2 |
| Regulation | 21 CFR 888.4580 |
| 510(k) | K031280 |
| Record published | 2021-11-21 |
| Record revised | 2025-05-30 (version 2) |
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 |
|---|---|---|
| 423876 | 8 mm | In distribution |
| 423826 | 3° 180 mm | In distribution |
| 423880 | 9.5 mm | In distribution |
| 423921 | 4 mm | In distribution |
| 423872 | 9.5 mm | In distribution |
| 423871 | 7 mm | In distribution |
| 423926 | 13 mm | In distribution |
| 423881 | 9.5 mm | In distribution |
| 423859 | 5 mm | In distribution |
| 423925 | 11 mm | In distribution |
| 423842 | 180 mm | In distribution |
Same Product Code
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.