AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor— 510(k) K213110

Substantially Equivalent

Auxein Medical Private Limited

FDA 510(k) clearance K213110 for AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor, Substantially Equivalent on 2022-12-16. Applicant: Auxein Medical Private Limited.

Clearance details

Applicant: Auxein Medical Private Limited
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2021-09-24
Decision date: 2022-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sonipat, IN

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.