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
- 510(k)K162236Substantially equivalent (SESE) · 2017-04-20clearance family
Predicate lineage
K162236
Cited as predicate by: K182139
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 |
|---|---|---|---|---|
| 2016-06-22 | NAI | No action indicated | Innovasis, Inc | 0 |
| 2012-04-27 | VAI | Voluntary action indicated | Innovasis, Inc | 6 |
Similar devices
- Idys®-ALIF 3DTI CLARIANCE
- Idys®-ALIF 3DTI CLARIANCE
- Idys®-LLIF CLARIANCE
- 37mm W X 28mm D X 18mm H, 20°, PILLAR SA Ti, STERILE Orthofix US LLC
- 3D Printed Interbody System Seaspine Orthopedics Corporation
- 3D Printed Interbody System Seaspine Orthopedics Corporation
- 3D Printed Interbody System Seaspine Orthopedics Corporation
- 3D Printed Interbody System Seaspine Orthopedics Corporation
- 3D Printed Interbody System Seaspine Orthopedics Corporation
- 3D Printed Interbody System Seaspine Orthopedics Corporation
- 3D Printed Interbody System Seaspine Orthopedics Corporation
- 3D Printed Interbody System Seaspine Orthopedics Corporation
Select up to two to place side-by-side with this device.