The following data is part of a premarket notification filed by Medartis Ag with the FDA for Aptus(r) Distal Humerus System.
| Device ID | K112560 |
| 510k Number | K112560 |
| Device Name: | APTUS(R) DISTAL HUMERUS SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | MEDARTIS AG 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | Kevin A Thomas |
| Correspondent | Kevin A Thomas MEDARTIS AG 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-02 |
| Decision Date | 2011-12-15 |
| Summary: | summary |