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 |