The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Mosaic Non-modular Proximal Body And Eas Offset Modular Humeral Head.
Device ID | K042321 |
510k Number | K042321 |
Device Name: | MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD |
Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw, IN 46581 -0587 |
Contact | Kacy Arnold |
Correspondent | Kacy Arnold BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw, IN 46581 -0587 |
Product Code | KWT |
CFR Regulation Number | 888.3650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-08-26 |
Decision Date | 2005-01-28 |
Summary: | summary |