The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System.
| Device ID | K160085 |
| 510k Number | K160085 |
| Device Name: | Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | ZIMMER GMBH SULZERALLEE 8 Winterthur, CH 8404 |
| Contact | Roberto Tommasini |
| Correspondent | Annemie Rehor Kausch ZIMMER GMBH SULZERALLEE 8 Winterthur, CH 8404 |
| Product Code | KWS |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWT |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-15 |
| Decision Date | 2016-03-08 |
| Summary: | summary |