The following data is part of a premarket notification filed by Custom Orthopaedic Solutions with the FDA for Arthrex Glenoid Intelligent Reusable Instrument System (arthrex Glenoid Iris).
| Device ID | K151500 |
| 510k Number | K151500 |
| Device Name: | Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | CUSTOM ORTHOPAEDIC SOLUTIONS 10000 CEDAR AVE Cleveland, OH 44106 |
| Contact | Peter D O'neill |
| Correspondent | Keith Grafmeyer CUSTOM ORTHOPAEDIC SOLUTIONS 10000 CEDAR AVE 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 | 2015-06-04 |
| Decision Date | 2015-10-05 |
| Summary: | summary |