The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Mallory/head Modular Calcar With And Without Ha.
Device ID | K031693 |
510k Number | K031693 |
Device Name: | MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | BIOMET, INC. 56 BELL DR. PO BOX 587 Warsaw, IN 46581 -0587 |
Contact | Patricia S Beres |
Correspondent | Patricia S Beres BIOMET, INC. 56 BELL DR. PO BOX 587 Warsaw, IN 46581 -0587 |
Product Code | LPH |
CFR Regulation Number | 888.3358 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-06-02 |
Decision Date | 2003-08-06 |
Summary: | summary |