ZipE Knotless Tissue Repair and Attachment Devices— 510(k) K162429

Substantially Equivalent

Ziptek, LLC

FDA 510(k) clearance K162429 for ZipE Knotless Tissue Repair and Attachment Devices, Substantially Equivalent on 2017-03-13. Applicant: Ziptek, LLC.

Clearance details

Applicant: Ziptek, LLC
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2016-08-30
Decision date: 2017-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
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.