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 |