THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA— 510(k) K133875
Substantially EquivalentOrtho Kinematics, Inc.
FDA 510(k) clearance K133875 for THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA, Substantially Equivalent on 2014-01-17. 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
- Special
- Location
- Washington, DC, 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
- K171617 — OKI Surgical Planning Software
- 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 →
Recalls naming K133875
K-number listed on FDA's recall record- Z-2889-2018 — Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological
- Z-2891-2018 — Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.
- Z-2882-2018 — Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files.
- Z-2890-2018 — Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133875.
Data sourced from openFDA. This site is unofficial and independent of the FDA.