The following data is part of a premarket notification filed by Zimmer with the FDA for Zimmer Psi Shoulder System.
| Device ID | K150730 |
| 510k Number | K150730 |
| Device Name: | Zimmer PSI Shoulder System |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | ZIMMER 75, QUEEN STREET, SUITE 3300 Montreal, CA H3c 2n6 |
| Contact | Christopher Mclean |
| Correspondent | Christopher Mclean ZIMMER 75, QUEEN STREET, SUITE 3300 Montreal, CA H3c 2n6 |
| Product Code | KWT |
| Subsequent Product Code | KWS |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-20 |
| Decision Date | 2015-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024305816 | K150730 | 000 |
| 00889024304178 | K150730 | 000 |
| 00889024304161 | K150730 | 000 |
| 00889024304154 | K150730 | 000 |
| 00889024304147 | K150730 | 000 |
| 00889024304130 | K150730 | 000 |
| 00889024304123 | K150730 | 000 |
| 00889024304079 | K150730 | 000 |
| 00889024211612 | K150730 | 000 |