The following data is part of a premarket notification filed by Custom Orthopaedic Solutions with the FDA for Orthovis Preoperative Plan.
| Device ID | K133367 |
| 510k Number | K133367 |
| Device Name: | ORTHOVIS PREOPERATIVE PLAN |
| Classification | System, Image Processing, Radiological |
| Applicant | CUSTOM ORTHOPAEDIC SOLUTIONS 10000 CEDAR AVE Cleveland, OH 44106 |
| Contact | Justin Baker |
| Correspondent | Justin Baker CUSTOM ORTHOPAEDIC SOLUTIONS 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 | 2013-11-01 |
| Decision Date | 2013-12-20 |
| Summary: | summary |