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: K110783, K120031, K124034, K130641, K131276, K142271, K150673, K163670, K170676, K180963, K251575
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.
- 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