The following data is part of a premarket notification filed by Orthohub, Inc. with the FDA for Orthohub External Fixator Software.
| Device ID | K140550 |
| 510k Number | K140550 |
| Device Name: | ORTHOHUB EXTERNAL FIXATOR SOFTWARE |
| Classification | Software For Diagnosis/treatment |
| Applicant | ORTHOHUB, INC. 999 MENLO OAKS DRIVE Menlo Park, CA 94025 |
| Contact | Peggy Mclaughlin |
| Correspondent | Peggy Mclaughlin ORTHOHUB, INC. 999 MENLO OAKS DRIVE Menlo Park, CA 94025 |
| Product Code | OSN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-04 |
| Decision Date | 2014-08-25 |
| Summary: | summary |