The following data is part of a premarket notification filed by Implantcast, Gmbh with the FDA for Agilon Xo Shoulder System.
| Device ID | K222482 |
| 510k Number | K222482 |
| Device Name: | AGILON XO Shoulder System |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | implantcast, GmbH Luneburger Schanze 26 Buxtehude, DE 21615 |
| Contact | Ms. Juliane Hoppner |
| Correspondent | Mr Dave McGurl MCRA, LLC 803 7th Street N.W., Floor 3 Washington, DC 20001 |
| Product Code | KWT |
| Subsequent Product Code | HSD |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-17 |
| Decision Date | 2022-09-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048844546687 | K222482 | 000 |
| 04048844546670 | K222482 | 000 |
| 04048844546663 | K222482 | 000 |
| 04048844546656 | K222482 | 000 |