JDN — Implant, Fixation Device, Spinal Class II
FDA product code JDN covers "Implant, Fixation Device, Spinal", a Class II medical device regulated under 21 CFR 888.3060. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JDN
- Device Class
- Class II
- Regulation Number
- 888.3060
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K954856 | synthes (usa) | CANNULATED FEMORAL NAIL | March 8, 1996 |
| K897141 | stuart | SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO | June 21, 1990 |
| K894184 | biedermann motech | BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM | April 25, 1990 |
| K872715 | roseburg | UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY | December 7, 1987 |
| K873977 | sofamor | NEW C-D SYSTEM FOR SPINAL SURGERY | December 7, 1987 |
| K760649 | depuy | TOTAL SPINAL CORRECTION | October 5, 1976 |