DeviceClearance

K212912

Substantially Equivalent

OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System

Applicant
B-One Ortho, Corp.
Product code
MAI
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cedar Knolls, NJ, US
Download summary PDF View on FDA.gov ↗

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 →

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