The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Ashcom Shoulder System, Anatomical Shoulder System And Anatomical Shoulder Combined System.
| Device ID | K170711 |
| 510k Number | K170711 |
| Device Name: | ASHCOM Shoulder System, Anatomical Shoulder System And Anatomical Shoulder Combined System |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | Zimmer GmbH Sulzerallee 8 Winterthur, CH 8404 |
| Contact | Roberto Tommasini |
| Correspondent | Annemie Rehor Kausch Zimmer GmbH Sulzerallee 8 Winterthur, CH 8404 |
| Product Code | PHX |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| Subsequent Product Code | PAO |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-08 |
| Decision Date | 2017-06-01 |
| Summary: | summary |