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 | K142569 |
| 510k Number | K142569 |
| 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 | Bryann Babb |
| Correspondent | Bryan Babb Aquila Consultants, LLC 3602 Glenview Avenue Glenview, KY 40025 |
| Product Code | KXE |
| CFR Regulation Number | 888.3810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-12 |
| Decision Date | 2015-04-03 |
| Summary: | summary |