The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Bio-modular Shoulder System.
Device ID | K992119 |
510k Number | K992119 |
Device Name: | BIO-MODULAR SHOULDER SYSTEM |
Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
Contact | Patricia Sandborn Beres |
Correspondent | Patricia Sandborn Beres BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
Product Code | KWS |
CFR Regulation Number | 888.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-06-23 |
Decision Date | 1999-09-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00880304214125 | K992119 | 000 |
00880304214101 | K992119 | 000 |
00880304116139 | K992119 | 000 |
00880304116122 | K992119 | 000 |