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)K223438Substantially equivalent (SESE) · 2023-02-10clearance family
- 510(k)K213978Substantially equivalent (SESE) · 2022-10-18clearance family
Predicate lineage
- K213978
Cited as predicate by: K223108
- K223108
- K233254
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
None in the loaded window.
Similar devices
- BMAC Bevel Needle - Two Pack Surgentec, LLC
- 2.0 - ACUTRAK 3 NANO INSTRUMENT KIT (1027-001) Eca Medical Instruments
- BMAC Bevel Needle Kit Surgentec, LLC
- BMAC Bevel Needle Kit - Two Pack Surgentec, LLC
- BMAC Bevel Needle Pouched Surgentec, LLC
- Guide Pin - Bevel Surgentec, LLC
- Site Prep Locator - Row Series Surgentec, LLC
- Anterior Cervical Interbody Fusion Device PRECISION SPINE, INC.
- BMAC Bevel Needle Surgentec, LLC
- BMAC Bevel Needle Assembly Surgentec, LLC
- BMAC Diamond Needle Surgentec, LLC
- BMAN Solid Diamond Needle Surgentec, LLC
Select up to two to place side-by-side with this device.