The following data is part of a premarket notification filed by Aptis Medical, Llc with the FDA for Aptis Medical Distal Radio Ulnar Joint Implant.
| Device ID | K190599 |
| 510k Number | K190599 |
| Device Name: | Aptis Medical Distal Radio Ulnar Joint Implant |
| Classification | Prosthesis, Wrist, Hemi-, Ulnar |
| Applicant | Aptis Medical, LLC 3602 Glenview Ave. Glenview, KY 40025 |
| Contact | Bryan Babb |
| Correspondent | Louise Focht ENMED Lntemtional, Inc PO Box 249 Del Mar, CA 92014 |
| Product Code | KXE |
| CFR Regulation Number | 888.3810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-08 |
| Decision Date | 2019-05-03 |