The following data is part of a premarket notification filed by Zimmer Cas with the FDA for Cas Psi Shoulder.
| Device ID | K131129 |
| 510k Number | K131129 |
| Device Name: | CAS PSI SHOULDER |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | ZIMMER CAS 1800 WEST CENTER STREET Warsaw, IN 46580 |
| Contact | Jason Heckaman |
| Correspondent | Jason Heckaman ZIMMER CAS 1800 WEST CENTER STREET Warsaw, IN 46580 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-22 |
| Decision Date | 2013-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024305809 | K131129 | 000 |
| 00889024305793 | K131129 | 000 |