The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for E1 Series A Patellae, Standard 3-peg, E1 Series A Patellae, Thin 3-peg, E1 Series Patellae, Asymmetrical, 3-peg.
| Device ID | K140902 |
| 510k Number | K140902 |
| Device Name: | E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Amy L Walriven |
| Correspondent | Amy L Walriven BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JWH |
| Subsequent Product Code | MBH |
| Subsequent Product Code | MBV |
| Subsequent Product Code | OIY |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-09 |
| Decision Date | 2014-07-03 |
| Summary: | summary |