DeviceClearance

Product code MAI— Orthopedic

Arthrex SwiveLock Anchors

Classification name
Fastener, Fixation, Biodegradable, Soft Tissue
Device class
Class 2
Regulation
21 CFR 888.3030
Advisory panel
Orthopedic
Total cleared
221
First cleared
Most recent

Market context for product code MAI

FDA has cleared 221 devices under product code MAI between 1994 and 2026, filed by 65 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 MAI

Adverse events under product code MAI

product code MAI
Injury
1,948
Malfunction
8,580
Total
10,528

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 MAI

1–100 of 221

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