The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Trident Crossfire Polyuethylene Liners.
| Device ID | K021911 |
| 510k Number | K021911 |
| Device Name: | TRIDENT CROSSFIRE POLYUETHYLENE LINERS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Debra Bing |
| Correspondent | Debra Bing 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 | 2002-06-11 |
| Decision Date | 2002-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327038552 | K021911 | 000 |
| 07613327023756 | K021911 | 000 |
| 07613327023787 | K021911 | 000 |
| 07613327024340 | K021911 | 000 |
| 07613327024371 | K021911 | 000 |
| 07613327024463 | K021911 | 000 |
| 07613327024470 | K021911 | 000 |
| 07613327024487 | K021911 | 000 |
| 07613327024517 | K021911 | 000 |
| 07613327025125 | K021911 | 000 |
| 07613327025132 | K021911 | 000 |
| 07613327023688 | K021911 | 000 |