The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for 100kgy E-poly Acetabular Liners-additional Profiles.
| Device ID | K070399 |
| 510k Number | K070399 |
| Device Name: | 100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIOMET MANUFACTURING, INC. P.O. BOX 587 Warsaw, IN 46581 -0578 |
| Contact | Tracy B Johnson |
| Correspondent | Tracy B Johnson BIOMET MANUFACTURING, INC. P.O. BOX 587 Warsaw, IN 46581 -0578 |
| Product Code | JDI |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | MAY |
| Subsequent Product Code | OQG |
| Subsequent Product Code | OQH |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-12 |
| Decision Date | 2007-05-04 |
| Summary: | summary |