The following data is part of a premarket notification filed by Custom Orthopaedic Solutions, Inc. with the FDA for Glenoid Intelligent Reusable Instrument System (glenoid Iris).
| Device ID | K142072 |
| 510k Number | K142072 |
| Device Name: | GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | CUSTOM ORTHOPAEDIC SOLUTIONS, INC. 10000 CEDAR AVENUE Cleveland, OH 44106 |
| Contact | Justin J Baker,phd |
| Correspondent | Justin J Baker,phd 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 | 2014-07-23 |
| Decision Date | 2014-11-24 |
| Summary: | summary |