The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Super Eon Plus Femoral Stems.
| Device ID | K020989 |
| 510k Number | K020989 |
| Device Name: | SUPER EON PLUS FEMORAL STEMS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Jennifer A Daudelin |
| Correspondent | Jennifer A Daudelin HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-27 |
| Decision Date | 2002-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327039160 | K020989 | 000 |
| 04546540003614 | K020989 | 000 |
| 04546540003621 | K020989 | 000 |
| 04546540003638 | K020989 | 000 |
| 04546540003645 | K020989 | 000 |
| 04546540003652 | K020989 | 000 |
| 04546540003669 | K020989 | 000 |
| 07613327039108 | K020989 | 000 |
| 07613327039115 | K020989 | 000 |
| 07613327039122 | K020989 | 000 |
| 07613327039139 | K020989 | 000 |
| 07613327039146 | K020989 | 000 |
| 07613327039153 | K020989 | 000 |
| 04546540003607 | K020989 | 000 |