The following data is part of a premarket notification filed by Fx Shoulder Usa, Inc. with the FDA for Tin Coated Humeral Head.
| Device ID | K191698 |
| 510k Number | K191698 |
| Device Name: | TiN Coated Humeral Head |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | FX Shoulder USA, Inc. 13465 Midway Road, Suite 101 Dallas, TX 75244 |
| Contact | Kathy Trier |
| Correspondent | Kathy Trier FX Shoulder USA, Inc. 13465 Midway Road, Suite 101 Dallas, TX 75244 |
| Product Code | KWT |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-25 |
| Decision Date | 2020-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701037309582 | K191698 | 000 |
| 03701037300886 | K191698 | 000 |
| 03701037300893 | K191698 | 000 |
| 03701037300909 | K191698 | 000 |
| 03701037300916 | K191698 | 000 |
| 03701037300923 | K191698 | 000 |
| 03701037300930 | K191698 | 000 |
| 03701037300954 | K191698 | 000 |
| 03701037300961 | K191698 | 000 |
| 03701037300978 | K191698 | 000 |
| 03701037300985 | K191698 | 000 |
| 03701037300992 | K191698 | 000 |
| 03701037301005 | K191698 | 000 |
| 03701037301012 | K191698 | 000 |
| 03701037309575 | K191698 | 000 |
| 03701037300879 | K191698 | 000 |