The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Durom Hip Resurfacing System, Femoral Components.
| Device ID | K070292 |
| 510k Number | K070292 |
| Device Name: | DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS |
| Classification | Prosthesis, Hip, Femoral, Resurfacing |
| Applicant | ZIMMER GMBH PO BOX 708 Warsaw, IN 46581 |
| Contact | Anthony Francalancia |
| Correspondent | Anthony Francalancia ZIMMER GMBH PO BOX 708 Warsaw, IN 46581 |
| Product Code | KXA |
| CFR Regulation Number | 888.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-31 |
| Decision Date | 2007-04-26 |
| Summary: | summary |