The following data is part of a premarket notification filed by Custom Orthopaedic Solutions, Inc. with the FDA for Smartbase For Arthrex Glenoid Iris.
| Device ID | K153215 |
| 510k Number | K153215 |
| Device Name: | SmartBase For Arthrex Glenoid IRIS |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | Custom Orthopaedic Solutions, Inc. 10000 Cedar Avenue Cleveland, OH 44106 |
| Contact | Keith Grafmeyer |
| Correspondent | Keith Grafmeyer Custom Orthopaedic Solutions, Inc. 10000 Cedar Avenue Cleveland, OH 44106 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-05 |
| Decision Date | 2016-02-19 |
| Summary: | summary |