Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
No recalls linked.
Predicate lineage
- K173487
Cited as predicate by: K182377, K192214, K193378, K200519, K200883, K201251, K201926, K203317, K210716, K232341, K233944
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2017-03-02 | VAI | Voluntary action indicated | CarboFix Orthopedics, Ltd. | 4 |
| 2017-03-02 | VAI | Voluntary action indicated | CarboFix Orthopedics, Ltd. | 4 |
- DSS Pedicle screw set, Ø5.0 x 50mm Paradigm Spine GmbH
- Facilis™ Spinal System BAUI BIOTECH CO. LTD.
- TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC.
- """LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System""" L&K BIOMED CO. ,LTD.
- """LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System""" L&K BIOMED CO. ,LTD.
- """LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System""" L&K BIOMED CO. ,LTD.
- """LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System""" L&K BIOMED CO. ,LTD.
- """LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System""" L&K BIOMED CO. ,LTD.
- """LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System""" L&K BIOMED CO. ,LTD.
- """LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System""" L&K BIOMED CO. ,LTD.
- """LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System""" L&K BIOMED CO. ,LTD.
- """LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System""" L&K BIOMED CO. ,LTD.