The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Durom Acetabular Component And Metasul Ldh Large Diameter Heads.
| Device ID | K053536 |
| 510k Number | K053536 |
| Device Name: | DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Laura D Williams |
| Correspondent | Laura D Williams ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | KWA |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-19 |
| Decision Date | 2006-03-16 |
| Summary: | summary |