The following data is part of a premarket notification filed by Medartis Ag with the FDA for Aptus K-wire System.
| Device ID | K092038 |
| 510k Number | K092038 |
| Device Name: | APTUS K-WIRE SYSTEM |
| Classification | Pin, Fixation, Smooth |
| Applicant | MEDARTIS AG 11234 EL CAMINO REAL, STE 200 San Diego, CA 92130 |
| Contact | Kevin Thomas |
| Correspondent | Kevin Thomas MEDARTIS AG 11234 EL CAMINO REAL, STE 200 San Diego, CA 92130 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-06 |
| Decision Date | 2009-09-23 |
| Summary: | summary |