510(k) K173247
K173247 is an FDA 510(k) premarket notification submitted by Ortho Kinematics, Inc. for the device "Surgical Planning Software version 1.1". The FDA issued a decision of Substantially Equivalent on November 8, 2017. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Ortho Kinematics, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 2017
- Date Received
- October 6, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type