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 | K040497 |
| 510k Number | K040497 |
| Device Name: | DISTAL RADIO-ULNAR JOINT IMPLANT |
| Classification | Prosthesis, Wrist, Hemi-, Ulnar |
| Applicant | APTIS MEDICAL, LLC. P.O. BOX 249 Del Mar, CA 92014 |
| Contact | Louise M Focht |
| Correspondent | Louise M Focht APTIS MEDICAL, LLC. P.O. 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 | 2004-02-26 |
| Decision Date | 2005-01-26 |
| Summary: | summary |