The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Hansson Pin System.
| Device ID | K033968 |
| 510k Number | K033968 |
| Device Name: | HANSSON PIN SYSTEM |
| Classification | Pin, Fixation, Smooth |
| Applicant | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Vivian Kelly |
| Correspondent | Vivian Kelly HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-22 |
| Decision Date | 2004-02-20 |
| Summary: | summary |