The following data is part of a premarket notification filed by Ortho Kinematics, Inc. with the FDA for Oki Surgical Planning Software.
| Device ID | K171617 |
| 510k Number | K171617 |
| Device Name: | OKI Surgical Planning Software |
| Classification | System, Image Processing, Radiological |
| Applicant | Ortho Kinematics, Inc. 110 Wild Basin Road, Suite 250 Austin, TX 78704 |
| Contact | Adam Deitz |
| Correspondent | John J. Smith Hogan Lovells US LLP 555 13th Street, NW Washington, DC 20004 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-01 |
| Decision Date | 2017-08-22 |
| Summary: | summary |