The following data is part of a premarket notification filed by Medartis Ag with the FDA for Aptus(r) Wrist 2.5 System.
| Device ID | K172170 |
| 510k Number | K172170 |
| Device Name: | APTUS(R) Wrist 2.5 System |
| Classification | Plate, 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-18 |
| Decision Date | 2017-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630037804888 | K172170 | 000 |
| 07630037804871 | K172170 | 000 |
| 07630037804864 | K172170 | 000 |
| 07630037804857 | K172170 | 000 |
| 07630037894568 | K172170 | 000 |
| 07630037894551 | K172170 | 000 |