The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Wagner Cone Prosthesis System.
Device ID | K113556 |
510k Number | K113556 |
Device Name: | WAGNER CONE PROSTHESIS SYSTEM |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
Applicant | ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Daniel J William |
Correspondent | Daniel J William ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
Product Code | LZO |
Subsequent Product Code | JDI |
Subsequent Product Code | KWZ |
Subsequent Product Code | LPH |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-12-01 |
Decision Date | 2012-02-17 |
Summary: | summary |