The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Metasul Taper Liners, Metasul Femoral Heads.
| Device ID | K091973 |
| 510k Number | K091973 |
| Device Name: | METASUL TAPER LINERS, METASUL FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Benjamin C Curson |
| Correspondent | Benjamin C Curson 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 | 2009-07-01 |
| Decision Date | 2009-11-17 |
| Summary: | summary |