The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Zimmer Porolock Mis Stem.
Device ID | K071723 |
510k Number | K071723 |
Device Name: | ZIMMER POROLOCK MIS STEM |
Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
Applicant | ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Dalene T Binkley |
Correspondent | Dalene T Binkley ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
Product Code | KWA |
Subsequent Product Code | JDI |
Subsequent Product Code | JDL |
Subsequent Product Code | KWL |
Subsequent Product Code | KWY |
Subsequent Product Code | KWZ |
Subsequent Product Code | LWJ |
Subsequent Product Code | LZO |
CFR Regulation Number | 888.3330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-06-25 |
Decision Date | 2008-03-07 |
Summary: | summary |