The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Alumina V40 Femoral Heads.
| Device ID | K023901 |
| 510k Number | K023901 |
| Device Name: | ALUMINA V40 FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Debra Bing |
| Correspondent | Debra Bing HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-22 |
| Decision Date | 2003-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540402141 | K023901 | 000 |
| 04546540402134 | K023901 | 000 |
| 04546540402127 | K023901 | 000 |
| 04546540390516 | K023901 | 000 |
| 04546540390509 | K023901 | 000 |
| 04546540390493 | K023901 | 000 |
| 04546540390486 | K023901 | 000 |
| 04546540390479 | K023901 | 000 |
| 04546540390462 | K023901 | 000 |