The following data is part of a premarket notification filed by Custom Orthopaedic Solutions, Inc. with the FDA for Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoid Iris, Arthrexvip Web Portal.
| Device ID | K162697 |
| 510k Number | K162697 |
| Device Name: | Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase For Arthrex Glenoid IRIS, ArthrexVIP Web Portal |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | Custom Orthopaedic Solutions, Inc. 7100 Euclid Ave., Ste. 180 Cleveland, OH 44103 |
| Contact | Keith Grafmeyer |
| Correspondent | Keith Grafmeyer Custom Orthopaedic Solutions, Inc. 7100 Euclid Ave., Ste. 180 Cleveland, OH 44103 |
| Product Code | KWS |
| Subsequent Product Code | LLZ |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-27 |
| Decision Date | 2017-02-10 |
| Summary: | summary |