The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for 44mm E1 Acetabular Liner With 44mm Biolox Delta Option Ceramic Head Or 44mm M A Magnum.
| Device ID | K093549 |
| 510k Number | K093549 |
| Device Name: | 44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| 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 | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | MAY |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-17 |
| Decision Date | 2009-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304510562 | K093549 | 000 |
| 00880304480780 | K093549 | 000 |
| 00880304480797 | K093549 | 000 |
| 00880304480803 | K093549 | 000 |
| 00880304480810 | K093549 | 000 |
| 00880304481060 | K093549 | 000 |
| 00880304481077 | K093549 | 000 |
| 00880304481084 | K093549 | 000 |
| 00880304484900 | K093549 | 000 |
| 00880304484917 | K093549 | 000 |
| 00880304484924 | K093549 | 000 |
| 00880304484931 | K093549 | 000 |
| 00887868248603 | K093549 | 000 |