The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Versa-dial Humeral Head.
Device ID | K040610 |
510k Number | K040610 |
Device Name: | VERSA-DIAL HUMERAL HEAD |
Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
Applicant | BIOMET MANUFACTURING, INC. P.O. BOX 587 Warsaw, IN 46581 -0578 |
Contact | Gary Baker |
Correspondent | Gary Baker BIOMET MANUFACTURING, INC. P.O. BOX 587 Warsaw, IN 46581 -0578 |
Product Code | KWS |
Subsequent Product Code | HSD |
Subsequent Product Code | KWT |
Subsequent Product Code | MBF |
CFR Regulation Number | 888.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-03-08 |
Decision Date | 2004-06-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00880304460812 | K040610 | 000 |
00880304460751 | K040610 | 000 |
00880304212244 | K040610 | 000 |
00880304212237 | K040610 | 000 |
00880304212220 | K040610 | 000 |
00880304212213 | K040610 | 000 |
00880304212206 | K040610 | 000 |
00880304212190 | K040610 | 000 |
00880304212183 | K040610 | 000 |