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)K192076Substantially equivalent (SESE) · 2019-08-29clearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2023-08-10 | NAI | No action indicated | Genesys Orthopedics Systems, LLC | 0 |
| 2017-09-08 | VAI | Voluntary action indicated | Genesys Orthopedics Systems, LLC | 1 |
| 2013-06-05 | NAI | No action indicated | Genesys Orthopedics Systems, LLC | 0 |
| 2012-04-02 | OAI | Official action indicated | Genesys Orthopedics Systems, LLC | 5 |
Similar devices
- 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.
- """12(w) x 15(d) Saber-C Bodies (PEEK) """ ELEVATION SPINE, INC.
- """12(w) x 15(d) Saber-C Bodies (PEEK) """ ELEVATION SPINE, INC.
- """12(w) x 15(d) Saber-C Bodies (PEEK) """ ELEVATION SPINE, INC.
- """12(w) x 15(d) Saber-C Bodies (PEEK) """ ELEVATION SPINE, INC.
- """12(w) x 15(d) Saber-C Bodies (PEEK) """ ELEVATION SPINE, INC.
- """12(w) x 15(d) Saber-C Bodies (PEEK) """ ELEVATION SPINE, INC.
- """12(w) x 15(d) Saber-C Bodies (PEEK) """ ELEVATION SPINE, INC.
Select up to two to place side-by-side with this device.