The following data is part of a premarket notification filed by Medartis Ag with the FDA for Aptus Wrist Arthrodesis Plates.
| Device ID | K192297 |
| 510k Number | K192297 |
| Device Name: | APTUS Wrist Arthrodesis Plates |
| Classification | Plate, Fixation, Bone |
| Applicant | Medartis AG Hochbergerstrasse 60E Basel, CH Ch-4057 |
| Contact | Andrea Kiefer-schweizer |
| Correspondent | Kevin A. Thomas PaxMed International, LLC 12264 El Camino Real, Suite 400 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 | 2019-08-23 |
| Decision Date | 2019-11-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630037894988 | K192297 | 000 |
| 07630037894971 | K192297 | 000 |
| 07630037894940 | K192297 | 000 |
| 07630037894933 | K192297 | 000 |
| 07630037894926 | K192297 | 000 |
| 07630037894919 | K192297 | 000 |
| 07630037894902 | K192297 | 000 |