The following data is part of a premarket notification filed by Custom Orthopaedic Solutions, Inc. with the FDA for Arthrex Orthovis Preoperative Plan.
| Device ID | K151568 |
| 510k Number | K151568 |
| Device Name: | Arthrex OrthoVis Preoperative Plan |
| Classification | System, Image Processing, Radiological |
| Applicant | Custom Orthopaedic Solutions, Inc. 10000 Cedar Ave. Cleveland, OH 44106 |
| Contact | Peter O'neill |
| Correspondent | Peter O'neill Custom Orthopaedic Solutions, Inc. 10000 Cedar Ave. Cleveland, OH 44106 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-10 |
| Decision Date | 2015-07-31 |
| Summary: | summary |