The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer R Total Shoulder Ii.
| Device ID | K790987 |
| 510k Number | K790987 |
| Device Name: | ZIMMER R TOTAL SHOULDER II |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | ZIMMER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KWT |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-05-25 |
| Decision Date | 1979-06-22 |