The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Modification To Trident All Poly Cup.
| Device ID | K010310 |
| 510k Number | K010310 |
| Device Name: | MODIFICATION TO TRIDENT ALL POLY CUP |
| 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 | 2001-02-01 |
| Decision Date | 2001-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327024210 | K010310 | 000 |
| 07613327024203 | K010310 | 000 |
| 07613327024180 | K010310 | 000 |
| 07613327024081 | K010310 | 000 |
| 07613327024029 | K010310 | 000 |
| 07613327024005 | K010310 | 000 |
| 07613327023923 | K010310 | 000 |