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
Cited as predicate by: K203520, K211903, K221049, K223190, K250540, K250764
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.
None in the loaded window.
- Anterior Cervical Interbody Fusion Device PRECISION SPINE, INC.
- Anterior Cervical Interbody Fusion Device PRECISION SPINE, INC.
- MD-Vue™ Lateral Discectomy System PRECISION SPINE, INC.
- NexGen Anterior Cervical Plate System PRECISION SPINE, INC.
- P.L.U.S.® SPINEVISION
- P.L.U.S.® SPINEVISION
- Slimplicity Anterior Cervical Plate System PRECISION SPINE, 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.