The following data is part of a premarket notification filed by Custom Orthopaedic Solutions, Inc. with the FDA for Arthrexvip Web Portal.
| Device ID | K153612 |
| 510k Number | K153612 |
| Device Name: | ArthrexVIP Web Portal |
| Classification | System, Image Processing, Radiological |
| 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 | LLZ |
| Subsequent Product Code | KWS |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-17 |
| Decision Date | 2016-03-15 |
| Summary: | summary |