The following data is part of a premarket notification filed by Otto Bock Austria with the FDA for Axon-bus Prosthetic System.
| Device ID | K123795 |
| 510k Number | K123795 |
| Device Name: | AXON-BUS PROSTHETIC SYSTEM |
| Classification | Electrode, Cutaneous |
| Applicant | OTTO BOCK AUSTRIA KAISERSTRASSE 39 Vienna, AT A-1070 |
| Contact | Reinhard Wolkerstorfer |
| Correspondent | Reinhard Wolkerstorfer OTTO BOCK AUSTRIA KAISERSTRASSE 39 Vienna, AT A-1070 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-10 |
| Decision Date | 2014-06-03 |
| Summary: | summary |