The following data is part of a premarket notification filed by Aptis Medical, Llc. with the FDA for Distal Radio-ulnar Joint Implant.
| Device ID | K053119 |
| 510k Number | K053119 |
| Device Name: | DISTAL RADIO-ULNAR JOINT IMPLANT |
| Classification | Prosthesis, Wrist, Hemi-, Ulnar |
| Applicant | APTIS MEDICAL, LLC. 5 RIVER HILL RD. Louisville, KY 40207 |
| Contact | Bryan Babb |
| Correspondent | Bryan Babb APTIS MEDICAL, LLC. 5 RIVER HILL RD. Louisville, KY 40207 |
| Product Code | KXE |
| CFR Regulation Number | 888.3810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-07 |
| Decision Date | 2005-12-07 |
| Summary: | summary |