OKI Surgical Planning Software— 510(k) K171617
Substantially EquivalentOrtho Kinematics, Inc.
FDA 510(k) clearance K171617 for OKI Surgical Planning Software, Substantially Equivalent on 2017-08-22. Applicant: Ortho Kinematics, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho Kinematics, Inc.
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Recent devices under product code LLZ
view allMore clearances from Ortho Kinematics, Inc.
view all- K173247 — Surgical Planning Software version 1.1
- K172327 — VMA System version 3.0
- K133875 — THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA
- K130743 — THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL
- K112109 — THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE
Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.