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 |