The following data is part of a premarket notification filed by Stryker Howmedica Osteonics with the FDA for Apex Pins.
| Device ID | K061493 |
| 510k Number | K061493 |
| Device Name: | APEX PINS |
| Classification | Pin, Fixation, Threaded |
| Applicant | STRYKER HOWMEDICA OSTEONICS 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Vivian Kelly |
| Correspondent | Vivian Kelly STRYKER HOWMEDICA OSTEONICS 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-31 |
| Decision Date | 2006-07-07 |
| Summary: | summary |