The following data is part of a premarket notification filed by Ortho Kinematics, Inc with the FDA for Surgical Planning Software Version 1.1.
| Device ID | K173247 |
| 510k Number | K173247 |
| Device Name: | Surgical Planning Software Version 1.1 |
| Classification | System, Image Processing, Radiological |
| Applicant | Ortho Kinematics, Inc 110 Wild Basin Road, Suite 250 Austin, TX 78746 |
| Contact | Adam Dietz |
| Correspondent | John J Smith Hogan Lovells Us Llp 553 13th Street, NW Washington, DC 20004 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-06 |
| Decision Date | 2017-11-08 |
| Summary: | summary |