The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Trident Elevated Rim Liner.
| Device ID | K020497 |
| 510k Number | K020497 |
| Device Name: | TRIDENT ELEVATED RIM LINER |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Nancy J Rieder |
| Correspondent | Nancy J Rieder HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-14 |
| Decision Date | 2002-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327024586 | K020497 | 000 |
| 07613327023862 | K020497 | 000 |
| 07613327023855 | K020497 | 000 |
| 07613327023848 | K020497 | 000 |
| 07613327023831 | K020497 | 000 |
| 07613327023824 | K020497 | 000 |
| 07613327023817 | K020497 | 000 |
| 07613327023800 | K020497 | 000 |
| 07613327023770 | K020497 | 000 |
| 07613327023879 | K020497 | 000 |
| 07613327023886 | K020497 | 000 |
| 07613327024531 | K020497 | 000 |
| 07613327024043 | K020497 | 000 |
| 07613327023961 | K020497 | 000 |
| 07613327023954 | K020497 | 000 |
| 07613327023930 | K020497 | 000 |
| 07613327023916 | K020497 | 000 |
| 07613327023909 | K020497 | 000 |
| 07613327023893 | K020497 | 000 |
| 07613327023763 | K020497 | 000 |