Panels › Orthopedic › Product code JDX · Class 2
Instrument, Surgical, Sonic And Accessory/Attachment
Regulation 888.4580
0510(k)s in 12 months (23 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in JDX
| Company | 510(k)s | Recalls |
|---|---|---|
| Orthosonics, Ltd. | 3 | 0 |
| Advanced Osseous Technologies | 2 | 0 |
| Buckman Co., Inc. | 2 | 0 |
| Mectron S.P.A. | 2 | 0 |
| Zimmer Biomet, Inc. | 0 | 2 |
| Amedica Corp. | 1 | 0 |
| Biomet, Inc. | 1 | 0 |
| Brassler USA | 1 | 0 |
| C.L. Mcintosh & Assoc., Inc. | 1 | 0 |
| Depuy, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2019 | Zimmer Biomet, Inc. Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bo Terminated |
JDX | K031280 |
| Jun 4, 2019 | Zimmer Biomet, Inc. Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone ceme Terminated |
JDX | K031280 |
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