The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Trident Large Diameter Hip System.
| Device ID | K061434 |
| 510k Number | K061434 |
| Device Name: | TRIDENT LARGE DIAMETER HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Tiffani Rogers |
| Correspondent | Tiffani Rogers HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-24 |
| Decision Date | 2006-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327032895 | K061434 | 000 |
| 07613327032680 | K061434 | 000 |
| 07613327032673 | K061434 | 000 |
| 07613327032666 | K061434 | 000 |
| 07613327032659 | K061434 | 000 |
| 07613327032642 | K061434 | 000 |
| 07613327032635 | K061434 | 000 |
| 07613327032628 | K061434 | 000 |
| 07613327032611 | K061434 | 000 |
| 07613327032604 | K061434 | 000 |
| 07613327025521 | K061434 | 000 |
| 07613327025415 | K061434 | 000 |
| 07613327025408 | K061434 | 000 |
| 07613327025392 | K061434 | 000 |
| 07613327025378 | K061434 | 000 |
| 07613327025361 | K061434 | 000 |
| 07613327025347 | K061434 | 000 |
| 07613327025330 | K061434 | 000 |
| 07613327032697 | K061434 | 000 |
| 07613327032703 | K061434 | 000 |
| 07613327032710 | K061434 | 000 |
| 07613327032888 | K061434 | 000 |
| 07613327032871 | K061434 | 000 |
| 07613327032864 | K061434 | 000 |
| 07613327032857 | K061434 | 000 |
| 07613327032840 | K061434 | 000 |
| 07613327032833 | K061434 | 000 |
| 07613327032826 | K061434 | 000 |
| 07613327032819 | K061434 | 000 |
| 07613327032802 | K061434 | 000 |
| 07613327032796 | K061434 | 000 |
| 07613327032789 | K061434 | 000 |
| 07613327032772 | K061434 | 000 |
| 07613327032765 | K061434 | 000 |
| 07613327032758 | K061434 | 000 |
| 07613327032741 | K061434 | 000 |
| 07613327032734 | K061434 | 000 |
| 07613327032727 | K061434 | 000 |
| 07613327025316 | K061434 | 000 |