The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Sidus Stem-free Shoulder.
| Device ID | K171858 |
| 510k Number | K171858 |
| Device Name: | Sidus Stem-Free Shoulder |
| Classification | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained |
| Applicant | Zimmer GmbH Sulzer Allee 8 Winterthur, CH 8404 |
| Contact | Roberto Tommasini |
| Correspondent | Dalene Binkley Zimmer, Inc. 1800 West Center Street Warsaw, IN 46580 |
| Product Code | PKC |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-21 |
| Decision Date | 2017-12-18 |
| Summary: | summary |