The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Anatomical Shoulder Keeled Glenoid.
| Device ID | K051623 |
| 510k Number | K051623 |
| Device Name: | ANATOMICAL SHOULDER KEELED GLENOID |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Brandon Hipsher |
| Correspondent | Brandon Hipsher ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-20 |
| Decision Date | 2005-07-19 |
| Summary: | summary |