Adverse-event reports (MAUDE)
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.
Recall history
No recalls linked.
Regulatory clearances
Predicate lineage
- K200793
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.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2017-01-26 | OAI | Official action indicated | L&K Biomed Co., Ltd. | 0 |
| 2017-01-26 | OAI | Official action indicated | L&K Biomed Co., Ltd. | 0 |
| 2014-06-05 | VAI | Voluntary action indicated | L&K Biomed Co., Ltd. | 0 |
| 2014-06-05 | VAI | Voluntary action indicated | L&K Biomed Co., Ltd. | 0 |
Similar devices
- Spinous Process Plate, 12mm Surgentec, LLC
- Spinous Process Plate, 16mm Surgentec, LLC
- P.L.U.S.® SPINEVISION
- P.L.U.S.® SPINEVISION
- Reform Pedicle Screw System PRECISION SPINE, INC.
- Spinous Process Plate, 10mm Surgentec, LLC
- Spinous Process Plate, 14mm Surgentec, LLC
- TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC.
- "icotec Systems, Handle, 1/4"" Coupling" icotec AG
- 3.5mm x 200mm Cervical Rods XENCO MEDICAL LLC
- 30 deg Offset Impactor KOROS U.S.A., INC.
- 30 deg Offset Impactor KOROS U.S.A., INC.
Select up to two to place side-by-side with this device.