The following data is part of a premarket notification filed by Custom Orthopaedic Solutions,inc. with the FDA for Orthovis Web Portal.
| Device ID | K151501 |
| 510k Number | K151501 |
| Device Name: | OrthoVis Web Portal |
| Classification | System, Image Processing, Radiological |
| Applicant | CUSTOM ORTHOPAEDIC SOLUTIONS,INC. 10000 CEDAR AVENUE Cleveland, OH 44106 |
| Contact | Justin Baker |
| Correspondent | Keith Grafmeyer CUSTOM ORTHOPAEDIC SOLUTIONS 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 | 2015-06-04 |
| Decision Date | 2015-10-02 |
| Summary: | summary |