The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Trident Large Diameter Acetabular Inserts.
| Device ID | K062419 |
| 510k Number | K062419 |
| Device Name: | TRIDENT LARGE DIAMETER ACETABULAR INSERTS |
| 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 | 2006-08-18 |
| Decision Date | 2006-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327025422 | K062419 | 000 |
| 07613327025385 | K062419 | 000 |
| 07613327025354 | K062419 | 000 |
| 07613327025323 | K062419 | 000 |
| 07613327025309 | K062419 | 000 |
| 07613327025293 | K062419 | 000 |
| 07613327025286 | K062419 | 000 |