Panels › General, Plastic Surgery › Product code JDK · Class 2
Prosthesis, Hip, Cement Restrictor
Regulation 878.3300
0510(k)s in 12 months (54 all time)
0recalls in 12 months (12 all time)
11recalls that name a 510(k)
Top companies in JDK
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek USA, Inc. | 7 | 0 |
| Encore Medical, Lp | 0 | 6 |
| Osteonics Corp. | 6 | 0 |
| Depuy Orthopaedics, Inc. | 0 | 5 |
| Spinal Concepts, Inc. | 5 | 0 |
| Interpore Cross Intl. | 2 | 0 |
| Life Spine | 2 | 0 |
| Spine Next SA | 2 | 0 |
| Theken Surgical,Llc | 2 | 0 |
| Amedica Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 29, 1987 | K872528 | OMNIFIT DISTAL STEM CEMENT SPACERS Osteonics Corp. | JDK |
| Mar 5, 1984 | K840413 | CEMENT RESTRICTOR American Ortomed Corp. | JDK |
| Sep 29, 1983 | K831512 | DOSIMETRY RELEASE OF RADIATION STERILIZ Biomet, Inc. | JDK |
| Jul 12, 1983 | K831128 | BARD INTRAMEDULLARY PLUG C.R. Bard, Inc. | JDK |
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