Si-Bone Inc.

483 adverse events · 30 clearances · 6 inspections · aggregated across 3 source records

Scorecard

Events per device across the 683-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.

MAUDE reports per device

0 →

0 in the last 12 months

Higher volume than 83% of companies with 10+ devices

Recalls per device

0 →

0 in the last 12 months

Higher volume than 97% of companies with 10+ devices

These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.

Devices

683 device records · ordered by linked event volume.

Brand	Model	Product codes	Primary DI	Linked events
iFuse Implant System	7055M-90	OUR	00851085007374	59
iFuse Implant System	7050M-90	OUR	00851085007367	54
iFuse Implant System	7060M-90	OUR	00851085007381	51
iFuse Implant System	7045M-90	OUR	00851085007350	39
iFuse Implant System	7040M-90	OUR	00851085007343	37
iFuse Implant System	7035M-90	OUR	00851085007305	32
iFuse Implant System	7070M-90	OUR	00851085007541	23
iFuse Implant System	7050-90	OUR	00859256003309	22
iFuse Implant System	7070M-100	OUR	00851085007459	21
iFuse Implant System	7055M-100	OUR	00851085007503	20
iFuse Implant System	7065M-90	OUR	00851085007442	14
iFuse Implant System	7040-90	OUR	00859256003286	14
iFuse Implant System	7075M-90	OUR	00851085007527	13
iFuse Implant System	7045-90	OUR	00859256003293	13
iFuse Implant System	7060M-100	OUR	00851085007534	10
iFuse Implant System	7065M-100	OUR	00851085007510	10
iFuse Implant System	7050M-100	OUR	00851085007497	10
iFuse Implant System	7030-90	OUR	00859256003262	9
iFuse Implant System	7080M-90	OUR	00851085007558	8
iFuse Implant System	7055-90	OUR	00859256003316	7
iFuse Implant System	7035M-100	OUR	00851085007466	6
iFuse Implant System	7065-90	OUR	00859256003330	5
iFuse Implant System	7045M-100	OUR	00851085007480	4
iFuse Implant System	7035-90	OUR	00859256003279	3
8.7 mm X 160 mm iFuse TORQ TNT Implant	870160	HWC OUR	00810055524402	2
iFuse Implant System	7040M-100	OUR	00851085007473	2
iFuse Implant System	7060-90	OUR	00859256003323	2
iFuse Implant System	7070-90	OUR	00859256003347	2
iFuse Implant System	4040-90	OUR	00859256003415	2
iFuse TORQ Implant System	10090LG	OUR	00810055520251	2

Showing 1–30 of 683Next →

Facilities

Registered establishments with their latest FDA inspection outcome.

FEI	Name	Location	Last inspection	Watch
3007700286	SI-BONE, INC.	Santa Clara, CA, US	NAI
3021948057	SI-BONE, INC.	Santa Clara, CA, US	NAI