X-Twist Biocomposite Suture Anchor— 510(k) K232513

Substantially Equivalent

Parcus Medical

FDA 510(k) clearance K232513 for X-Twist Biocomposite Suture Anchor, Substantially Equivalent on 2023-09-18. Applicant: Parcus Medical.

Clearance details

Applicant: Parcus Medical
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2023-08-18
Decision date: 2023-09-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Sarasota, FL, 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.