The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Trident Screw Hole Plug And Trident Bone Spike.
| Device ID | K022799 |
| 510k Number | K022799 |
| Device Name: | TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Margaret F Crowe |
| Correspondent | Margaret F Crowe HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | JDI |
| Subsequent Product Code | HWC |
| Subsequent Product Code | LPH |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-23 |
| Decision Date | 2002-11-21 |
| Summary: | summary |