The following data is part of a premarket notification filed by Medartis Ag with the FDA for Aptus Foot System.
| Device ID | K191636 |
| 510k Number | K191636 |
| Device Name: | APTUS Foot System |
| Classification | Staple, Fixation, Bone |
| Applicant | Medartis AG Hochbergerstrasse 60E Basel, CH Ch-4057 |
| Contact | Andrea Schweizer |
| Correspondent | Kevin A. Thomas PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | JDR |
| Subsequent Product Code | HRS |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-19 |
| Decision Date | 2019-08-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630037827672 | K191636 | 000 |
| 07630037827665 | K191636 | 000 |
| 07630037827658 | K191636 | 000 |
| 07630037827450 | K191636 | 000 |
| 07630037889380 | K191636 | 000 |
| 07630037889373 | K191636 | 000 |
| 07630037889366 | K191636 | 000 |