The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Zimmer Mmc Cup.
Device ID | K091003 |
510k Number | K091003 |
Device Name: | ZIMMER MMC CUP |
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 | 2009-04-08 |
Decision Date | 2009-11-24 |