The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for 100kgy E-poly Acetabular Liners- Additional Profiles: +3 Maxrom And +3 Hi-wall.
| Device ID | K090103 |
| 510k Number | K090103 |
| Device Name: | 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Becky Earl |
| Correspondent | Becky Earl BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | MAY |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | OQG |
| Subsequent Product Code | OQH |
| Subsequent Product Code | OQI |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-15 |
| Decision Date | 2009-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304647695 | K090103 | 000 |
| 00880304468979 | K090103 | 000 |
| 00880304468986 | K090103 | 000 |
| 00880304468993 | K090103 | 000 |
| 00880304469006 | K090103 | 000 |
| 00880304469013 | K090103 | 000 |
| 00880304469020 | K090103 | 000 |
| 00880304469037 | K090103 | 000 |
| 00880304469044 | K090103 | 000 |
| 00880304469051 | K090103 | 000 |
| 00880304469068 | K090103 | 000 |
| 00880304469075 | K090103 | 000 |
| 00880304469082 | K090103 | 000 |
| 00880304469099 | K090103 | 000 |
| 00880304484801 | K090103 | 000 |
| 00880304468962 | K090103 | 000 |