The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for E1 Antioxidant Infused Technology.
| Device ID | K100048 |
| 510k Number | K100048 |
| Device Name: | E1 ANTIOXIDANT INFUSED TECHNOLOGY |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive |
| Applicant | BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Becky Earl |
| Correspondent | Becky Earl BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | OIY |
| Subsequent Product Code | JDI |
| Subsequent Product Code | JWH |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MAY |
| Subsequent Product Code | OQG |
| Subsequent Product Code | OQH |
| Subsequent Product Code | OQI |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-08 |
| Decision Date | 2010-03-09 |
| Summary: | summary |