DeviceClearance

Product code MBI— Orthopedic

Arthrex FiberTak Suture Anchor

Classification name
Fastener, Fixation, Nondegradable, Soft Tissue
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Total cleared
603
First cleared
Most recent

Market context for product code MBI

FDA has cleared 603 devices under product code MBI between 1995 and 2026, filed by 163 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code MBI

Adverse events under product code MBI

product code MBI
Injury
3,163
Malfunction
13,006
Other
2
Total
16,171

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code MBI

1–100 of 603

Data sourced from openFDA. This site is unofficial and independent of the FDA.