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: K150474, K153370, K161498, K172139, K181350, K181949, K190895, K192013, K192646, K200571, K203319
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.
- DSS Pedicle screw set, Ø5.0 x 50mm Paradigm Spine GmbH
- POLYAXIAL SCREW, 5.5 CAPTIVA SPINE, INC.
- POLYAXIAL SCREW, 5.5 x 45 CAPTIVA SPINE, INC.
- Polyaxial Screw, 4.9 x 30 CAPTIVA SPINE, INC.
- Polyaxial Screw, 4.9 x 30 CAPTIVA SPINE, INC.
- Polyaxial Screw, 4.9 x 35 CAPTIVA SPINE, INC.
- Polyaxial Screw, 4.9 x 35 CAPTIVA SPINE, INC.
- Polyaxial Screw, 4.9 x 40 CAPTIVA SPINE, INC.
- Polyaxial Screw, 4.9 x 40 CAPTIVA SPINE, INC.
- Polyaxial Screw, 4.9 x 45 CAPTIVA SPINE, INC.
- Polyaxial Screw, 4.9 x 45 CAPTIVA SPINE, INC.
- Polyaxial Screw, 4.9 x 50 CAPTIVA SPINE, INC.