OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System— 510(k) K212912

Substantially Equivalent

B-One Ortho, Corp.

FDA 510(k) clearance K212912 for OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System, Substantially Equivalent on 2021-11-04. Applicant: B-One Ortho, Corp..

Clearance details

Applicant: B-One Ortho, Corp.
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2021-09-13
Decision date: 2021-11-04
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, 2020-01-01 through 2026-04-23. 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.