The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Trident All Poly Cup.
| Device ID | K001956 |
| 510k Number | K001956 |
| Device Name: | 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 | Karen Ariemma |
| Correspondent | Karen Ariemma HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-27 |
| Decision Date | 2000-12-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327024302 | K001956 | 000 |
| 07613327024111 | K001956 | 000 |
| 07613327024104 | K001956 | 000 |
| 07613327024098 | K001956 | 000 |
| 07613327024074 | K001956 | 000 |
| 07613327024067 | K001956 | 000 |
| 07613327024050 | K001956 | 000 |
| 07613327024036 | K001956 | 000 |
| 07613327024012 | K001956 | 000 |
| 07613327023992 | K001956 | 000 |
| 07613327023985 | K001956 | 000 |
| 07613327023978 | K001956 | 000 |
| 07613327024128 | K001956 | 000 |
| 07613327024135 | K001956 | 000 |
| 07613327024142 | K001956 | 000 |
| 07613327024296 | K001956 | 000 |
| 07613327024272 | K001956 | 000 |
| 07613327024265 | K001956 | 000 |
| 07613327024258 | K001956 | 000 |
| 07613327024241 | K001956 | 000 |
| 07613327024234 | K001956 | 000 |
| 07613327024227 | K001956 | 000 |
| 07613327024197 | K001956 | 000 |
| 07613327024173 | K001956 | 000 |
| 07613327024166 | K001956 | 000 |
| 07613327024159 | K001956 | 000 |
| 07613327023947 | K001956 | 000 |