The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Titanium Versa-dial Humeral Head Prosthesis.
Device ID | K140390 |
510k Number | K140390 |
Device Name: | TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS |
Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented |
Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
Contact | Brian Kincaid |
Correspondent | Brian Kincaid BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
Product Code | MBF |
Subsequent Product Code | HSD |
Subsequent Product Code | KWS |
Subsequent Product Code | KWT |
CFR Regulation Number | 888.3670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-02-14 |
Decision Date | 2014-09-10 |
Summary: | summary |